The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00098722




Registration number
NCT00098722
Ethics application status
Date submitted
7/12/2004
Date registered
8/12/2004
Date last updated
16/05/2012

Titles & IDs
Public title
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects
Secondary ID [1] 0 0
A4001028
Universal Trial Number (UTN)
Trial acronym
MOTIVATE 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Maraviroc (UK-427,857)
Treatment: Drugs - optimized background therapy
Treatment: Drugs - Maraviroc (UK-427,857)
Treatment: Drugs - optimized background therapy
Treatment: Drugs - optimized background therapy

Experimental: 1 -

Placebo Comparator: 2 -

Experimental: 3 -


Treatment: Drugs: Maraviroc (UK-427,857)
maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.

Treatment: Drugs: optimized background therapy
[OBT (3-6 drugs based on treatment history and resistance testing)]

Treatment: Drugs: Maraviroc (UK-427,857)
maraviroc (UK-427,857) 150 mg taken twice daily

Treatment: Drugs: optimized background therapy
[OBT (3-6 drugs based on treatment history and resistance testing)]

Treatment: Drugs: optimized background therapy
[OBT (3-6 drugs based on treatment history and resistance testing)]

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline - Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24 - Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Timepoint [2] 0 0
Baseline and Week 24
Primary outcome [3] 0 0
Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48 - Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Timepoint [3] 0 0
Baseline and Week 48
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL
Timepoint [1] 0 0
Week 24 and 48
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 0.5 log10 Decrease From Baseline
Timepoint [2] 0 0
Week 24 and 48
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/ml or With at Least 1.0 log10 Decrease From Baseline
Timepoint [3] 0 0
Week 24 and 48
Secondary outcome [4] 0 0
Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL
Timepoint [4] 0 0
Week 24 and 48
Secondary outcome [5] 0 0
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline - Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Change From Baseline in CD4 Cell Count at Week 24 and 48 - Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Timepoint [6] 0 0
Week 24 and 48
Secondary outcome [7] 0 0
Change From Baseline in CD8 Cell Count at Week 24 and 48 - Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.
Timepoint [7] 0 0
Week 24 and 48
Secondary outcome [8] 0 0
Time to Virological Failure - Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up[LTFU];new anti-retroviral drug added [except background drug change to drug of same class];or on open label for early non-response or rebound). Failure:at Time 0 if level not <400 copies/mL (2 consecutive visits) before events or last available visit;at time of earliest event if level <400 copies/mL (2 consecutive visits);failure if level >=400 copies/mL (2 consecutive visits) or 1 visit >=400 copies/mL followed by permanent discontinuation of drug or LTFU.
Timepoint [8] 0 0
Week 48
Secondary outcome [9] 0 0
Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels - TAD from baseline was calculated as area under the curve of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.
Timepoint [9] 0 0
Baseline to Week 24 and Week 48
Secondary outcome [10] 0 0
Number of Participants With Genotypic Susceptibility Score (GSS) and Phenotypic Susceptibility Score (PSS) at Screening - Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs) and non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Timepoint [10] 0 0
Screening
Secondary outcome [11] 0 0
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24 - Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Timepoint [11] 0 0
Screening and time of failure through Week 24
Secondary outcome [12] 0 0
Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 48 - Number of participants with GSS and PSS were used as surrogates for genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs, NNRTIs were evaluated at screening and time of treatment failure analyzed through Week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to >3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.
Timepoint [12] 0 0
Screening and time of failure through Week 48
Secondary outcome [13] 0 0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24 - Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} [R5], C-X-C chemokine receptor type 4 {CXCR4} [X4], Dual/Mixed [DM], or Non-reportable/Non-phenotypable [NR/NP]) at baseline and time of treatment failure analyzed through week 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.
Timepoint [13] 0 0
Baseline and time of failure through Week 24
Secondary outcome [14] 0 0
Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48 - Number of participants per tropism status R5, X4, DM, or NR/NP at baseline and time of failure analyzed through week 48 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load <500 copies/ml categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.
Timepoint [14] 0 0
Baseline and time of failure through Week 48
Secondary outcome [15] 0 0
Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening - Association between baseline resistance and virological response was assessed as change in viral load by OSS at screening. OSS categorized as 0, 1, 2, >3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility. Baseline value is the average of the values from screening, randomization and immediately pre-dose.
Timepoint [15] 0 0
Baseline, Week 24 and Week 48

Eligibility
Key inclusion criteria
- Men or women at least 16 yers of age (or minimum age as determined by local regulatory
authorities)

- HIV-1 RNA viral load of greater than or equal to 5,000 copies/mL

- Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least
4 weeks

- Documented genotypic or phenotypic resistance to three of the four antiretroviral drug
classes, OR, Antiretroviral-class experience greater than or equal to 6 months
(sequential or cumulative) with at least three of the following: One nucleoside or
nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase
inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide

- Be willing to remain on randomized treatment without any changes or additions to the
OBT regimen, except for toxicity management or upon meeting criteria for treatment
failure

- A negative urine pregnancy test at the baseline visit for Women of Child Bearing
Potential (WOCBP)

- Effective barrier contraception for WOCBP and males
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients requiring treatment with more than 6 antiretroviral agents (excluding
low-dose ritonavir)

- Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry
inhibitor for more than 14 days

- Suspected or documented active, untreated HIV-1 related opportunistic infection (OI)
or other condition requiring acute therapy

- Treatment for an active opportunistic infection, or unexplained temperature >38.5
degrees Celsius for 7 consecutive days

- Active alcohol or substance abuse sufficient, in the Investigator's judgment, to
prevent adherence to study medication and/or follow up

- Lactating women, or planned pregnancy during the trial period

- Significant renal insufficiency

- Initiating therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or
cytotoxic agent within 60 days prior to randomization or the expected need for such
therapy during the study period

- Documented or suspected acute hepatitis or pancreatitis within 30 days prior to
randomization

- Significantly elevated liver enzymes or cirrhosis

- Significant neutropenia, anemia or thrombocytopenia

- Malabsorption or an inability to tolerate oral medications

- Certain medications

- Malignancy requiring parenteral chemotherapy that must be continued for the duration
of the trial

- X4- or dual/mixed-tropic virus or repeated assay failure

- Any other clinical condition that, in the Investigator's judgement, would potentially
compromise study compliance or the ability to evaluate safety/efficacy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Burwood
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Darlinghurst
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Surry Hills
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Sydney
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Wentworthville
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Herston
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Miami
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Melbourne
Recruitment hospital [9] 0 0
Pfizer Investigational Site - North Fitzroy
Recruitment hospital [10] 0 0
Pfizer Investigational Site - South Yarra
Recruitment postcode(s) [1] 0 0
2134 - Burwood
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2010 - Surry Hills
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Wentworthville
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4220 - Miami
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3068 - North Fitzroy
Recruitment postcode(s) [10] 0 0
3141 - South Yarra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Belgium
State/province [21] 0 0
Brussels
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Belgium
State/province [23] 0 0
Liege
Country [24] 0 0
Canada
State/province [24] 0 0
Quebec
Country [25] 0 0
France
State/province [25] 0 0
Bp1412
Country [26] 0 0
France
State/province [26] 0 0
Cedex 02
Country [27] 0 0
France
State/province [27] 0 0
Cedex 09
Country [28] 0 0
France
State/province [28] 0 0
Cedex 10
Country [29] 0 0
France
State/province [29] 0 0
Cedex 12
Country [30] 0 0
France
State/province [30] 0 0
Cedex
Country [31] 0 0
France
State/province [31] 0 0
Le Kremlin Bicêtre
Country [32] 0 0
France
State/province [32] 0 0
Montpellier
Country [33] 0 0
France
State/province [33] 0 0
Nantes
Country [34] 0 0
France
State/province [34] 0 0
Nice Cedex 3, 06
Country [35] 0 0
France
State/province [35] 0 0
Paris, 75
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
Germany
State/province [37] 0 0
Aachen
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Bochum
Country [40] 0 0
Germany
State/province [40] 0 0
Bonn
Country [41] 0 0
Germany
State/province [41] 0 0
Duesseldorf
Country [42] 0 0
Germany
State/province [42] 0 0
Erlangen
Country [43] 0 0
Germany
State/province [43] 0 0
Essen
Country [44] 0 0
Germany
State/province [44] 0 0
Frankfurt
Country [45] 0 0
Germany
State/province [45] 0 0
Freiburg
Country [46] 0 0
Germany
State/province [46] 0 0
Fuerth
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Hannover
Country [49] 0 0
Germany
State/province [49] 0 0
Koeln
Country [50] 0 0
Germany
State/province [50] 0 0
Mannheim
Country [51] 0 0
Germany
State/province [51] 0 0
Muenchen
Country [52] 0 0
Germany
State/province [52] 0 0
Osnabrueck
Country [53] 0 0
Germany
State/province [53] 0 0
Stuttgart
Country [54] 0 0
Germany
State/province [54] 0 0
Ulm
Country [55] 0 0
Italy
State/province [55] 0 0
Antella (FI)
Country [56] 0 0
Italy
State/province [56] 0 0
Brescia
Country [57] 0 0
Italy
State/province [57] 0 0
Firenze
Country [58] 0 0
Italy
State/province [58] 0 0
Genova
Country [59] 0 0
Italy
State/province [59] 0 0
Milano
Country [60] 0 0
Italy
State/province [60] 0 0
Modena
Country [61] 0 0
Italy
State/province [61] 0 0
Monserrato, CA
Country [62] 0 0
Italy
State/province [62] 0 0
Roma
Country [63] 0 0
Italy
State/province [63] 0 0
Torino
Country [64] 0 0
Italy
State/province [64] 0 0
Venezia
Country [65] 0 0
Netherlands
State/province [65] 0 0
Amsterdam
Country [66] 0 0
Netherlands
State/province [66] 0 0
Arnhem
Country [67] 0 0
Netherlands
State/province [67] 0 0
Rotterdam
Country [68] 0 0
Netherlands
State/province [68] 0 0
Utrecht
Country [69] 0 0
Poland
State/province [69] 0 0
Bialystok
Country [70] 0 0
Poland
State/province [70] 0 0
Bydgoszcz
Country [71] 0 0
Poland
State/province [71] 0 0
Chorzow
Country [72] 0 0
Poland
State/province [72] 0 0
Gdansk
Country [73] 0 0
Poland
State/province [73] 0 0
Krakow
Country [74] 0 0
Poland
State/province [74] 0 0
Szczecin
Country [75] 0 0
Poland
State/province [75] 0 0
Warszawa
Country [76] 0 0
Spain
State/province [76] 0 0
Alicante
Country [77] 0 0
Spain
State/province [77] 0 0
Barcelona
Country [78] 0 0
Spain
State/province [78] 0 0
Cordoba
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
San Sebastian
Country [81] 0 0
Spain
State/province [81] 0 0
Sevilla
Country [82] 0 0
Sweden
State/province [82] 0 0
Stockholm
Country [83] 0 0
Sweden
State/province [83] 0 0
Göteborg
Country [84] 0 0
Sweden
State/province [84] 0 0
Malmö
Country [85] 0 0
Switzerland
State/province [85] 0 0
Basel
Country [86] 0 0
Switzerland
State/province [86] 0 0
Genève
Country [87] 0 0
Switzerland
State/province [87] 0 0
Lausanne
Country [88] 0 0
Switzerland
State/province [88] 0 0
Lugano
Country [89] 0 0
Switzerland
State/province [89] 0 0
St. Gallen
Country [90] 0 0
Switzerland
State/province [90] 0 0
Zürich
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Leics
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Loth
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Birmingham
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Brighton
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Edinburgh
Country [96] 0 0
United Kingdom
State/province [96] 0 0
London
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Manchester
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Newcastle Upon Tyre

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ViiV Healthcare
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown
to be active in vitro against a wide range of clinical isolates (including those resistant to
existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy
for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available
agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300
mg twice daily. No significant effects were seen on the QTc interval. The purpose of this
study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected,
treatment experienced patients who are failing their current antiretroviral regimen and
infected with R5-tropic virus exclusively. This study will involve more than 100 centers in
Europe and Australia to achieve a total randomized subject population of 500 subjects.
Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background
Therapy [OBT (3-6 drugs based on treatment history and resistance testing)] + maraviroc
(UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily,
or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of
treatment. This may be extended for an additional year depending on the results at 48 weeks.
Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40
and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32,
40 and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at
weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical
study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients
will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.
Trial website
https://clinicaltrials.gov/show/NCT00098722
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications