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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00553267




Registration number
NCT00553267
Ethics application status
Date submitted
8/10/2007
Date registered
5/11/2007
Date last updated
13/02/2014

Titles & IDs
Public title
Telmisartan/Amlodipine (80/10) vs. Telmisartan/Amlodipine (40/10) vs. amlodipine10 in Resistant Hypertension
Scientific title
An Eight-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 40mg + Amlodipine 10mg Versus Telmisartan 80mg + Amlodipine 10mg Versus Amlodipine 10mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 10mg Monotherapy
Secondary ID [1] 0 0
EUDRACT 2007-002421-68
Secondary ID [2] 0 0
1235.6
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - fixed dose combination of telmisartan+amlodipine
Treatment: Drugs - amlodipine

Treatment: Drugs: fixed dose combination of telmisartan+amlodipine


Treatment: Drugs: amlodipine


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

Outcomes
Primary outcome [1] 0 0
Change From Baseline in Trough Seated Diastolic Blood Pressure - Change from baseline to the end of study in trough DBP
Timepoint [1] 0 0
Baseline and end of study (8 weeks or last value on treatment)
Secondary outcome [1] 0 0
Change From Baseline in Trough Seated Systolic Blood Pressure - Change from baseline to the end of study in trough SBP
Timepoint [1] 0 0
Baseline and end of study (8 weeks or last value on treatment)
Secondary outcome [2] 0 0
Trough Seated Diastolic Blood Pressure Control (Defined as < 90mmHg) - The number of patients who reach the target DBP of <90mmHg
Timepoint [2] 0 0
End of study (8 weeks or last value on treatment)
Secondary outcome [3] 0 0
Trough Seated Diastolic Blood Pressure <80 mmHg - The number of patients who reach the target DBP of <80mmHg
Timepoint [3] 0 0
End of study (8 weeks or last value on treatment)
Secondary outcome [4] 0 0
Trough Seated DBP Response - The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg
Timepoint [4] 0 0
End of study (8 weeks or last value on treatment)
Secondary outcome [5] 0 0
Trough Seated SBP Control - The number of patients who reach the target SBP of <140mmHg
Timepoint [5] 0 0
End of study (8 weeks or last value on treatment)
Secondary outcome [6] 0 0
Trough Seated SBP Response - The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg
Timepoint [6] 0 0
End of study (8 weeks or last value on treatment)
Secondary outcome [7] 0 0
Trough Seated BP Normality Classes - The number of patients who reach predefined BP categories
Timepoint [7] 0 0
End of study (8 weeks or last value on treatment)
Secondary outcome [8] 0 0
Oedema Incidence Rate - The number of patients who experienced at least one case of oedema or worsening of oedema for the first time (expressed as number of patients/100 patient-years)
Timepoint [8] 0 0
During randomised treatment period
Secondary outcome [9] 0 0
Peripheral Oedema Incidence Rate - The number of cases of peripheral oedema (expressed as number of cases/100 patient-years)
Timepoint [9] 0 0
During randomised treatment period

Eligibility
Key inclusion criteria
- diagnosis of essential hypertension and blood pressure not adequately controlled
before informed consent (inadequate control defined as seated diastolic blood pressure
(DBP) >= 95 mmHg if on existing antihypertensive treatment or seated DBP >= 100 mmHg
if treatment-naïve).

- failure to respond to six weeks treatment with amlodipine 10mg. (Failure to respond
defined as seated DBP >= 90 mmHg.)

- able to stop any current antihypertensive therapy without unacceptable risk to the
patient.

- willing and able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- pregnancy, breast-feeding, unwilling to use effective contraception (if female of
child-bearing potential).

- known or suspected secondary hypertension.

- mean seated systolic blood pressure (SBP) >=200 mmHg and/or mean seated DBP >= 120
mmHg during run-in treatment or mean seated SBP >= 180 mmHg and/or mean seated DBP >=
120 mmHg at the randomisation visit or at any time during randomised treatment.

- any clinically significant hepatic impairment or severe renal impairment bilateral
renal artery stenosis or renal artery stenosis in a solitary kidney or post post-renal
transplant.

- clinically relevant hyperkalaemia.

- uncorrected volume or sodium depletion.

- primary aldosteronism.

- hereditary fructose or lactose intolerance.

- symptomatic congestive heart failure.

- patients who have previously experienced symptoms characteristic of angioedema during
treatment with ACE inhibitors or ARBs.

- history of drug or alcohol dependency within the six months prior to signing consent.

- concurrent participation in another clinical trial or any investigational therapy
within thirty days prior to signing consent.

- hypertrophic obstructive cardiomyopathy, hemodynamically relevant stenosis of the
aortic or mitral valve.

- known allergic hypersensitivity to any component of the formulations under
investigation. (Includes known hypersensitivity to telmisartan or other ARBs or
amlodipine or other dihydropyridine CCBs.)

- non-compliance with study medication (defined as less than 80% or more than 120%)
during the open-label run-in treatment period.

- current treatment with any antihypertensive agents, whether or not prescribed for this
indication, that cannot be safely stopped (investigator¿s decision) by the start of
the run-in period.

- chronic administration of any medication known to affect blood pressure, other than
the trial medication.

- any other clinical condition which, in the opinion of the investigator, would not
allow safe completion of the protocol and safe administration of telmisartan and
amlodipine.

Study design
Purpose of the study
Treatment
Allocation to intervention
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?



Intervention assignment
Parallel
Other design features
Phase
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,SA
Recruitment hospital [1] 0 0
1235.6.61003 Boehringer Ingelheim Investigational Site - Gosford
Recruitment hospital [2] 0 0
1235.6.61004 Boehringer Ingelheim Investigational Site - Liverpool
Recruitment hospital [3] 0 0
1235.6.61002 Boehringer Ingelheim Investigational Site - Kippa-Ring
Recruitment hospital [4] 0 0
1235.6.61001 Boehringer Ingelheim Investigational Site - Milton
Recruitment hospital [5] 0 0
1235.6.61005 Boehringer Ingelheim Investigational Site - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- Liverpool
Recruitment postcode(s) [3] 0 0
- Kippa-Ring
Recruitment postcode(s) [4] 0 0
- Milton
Recruitment postcode(s) [5] 0 0
- Elizabeth Vale
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Eggenburg
Country [2] 0 0
Austria
State/province [2] 0 0
Hainburg a.d. Donau
Country [3] 0 0
Austria
State/province [3] 0 0
Hartberg
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Bourgas
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Sofia
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Varna
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Benatky nad Jizerou
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Brno
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Plzen
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha 5
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Pribram
Country [13] 0 0
Czech Republic
State/province [13] 0 0
Slany
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Strakonice
Country [15] 0 0
Ireland
State/province [15] 0 0
Birr
Country [16] 0 0
Ireland
State/province [16] 0 0
Carrigtwohill
Country [17] 0 0
Ireland
State/province [17] 0 0
Enniscorthy
Country [18] 0 0
Ireland
State/province [18] 0 0
Gorey
Country [19] 0 0
Ireland
State/province [19] 0 0
Mallow
Country [20] 0 0
Ireland
State/province [20] 0 0
New Ross
Country [21] 0 0
Italy
State/province [21] 0 0
Broni (pv)
Country [22] 0 0
Italy
State/province [22] 0 0
Coppito (AQ)
Country [23] 0 0
Italy
State/province [23] 0 0
Ferrara
Country [24] 0 0
New Zealand
State/province [24] 0 0
Dunedin
Country [25] 0 0
New Zealand
State/province [25] 0 0
Otahuhu, Auckland
Country [26] 0 0
New Zealand
State/province [26] 0 0
Tauranga
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Russian Federation
State/province [28] 0 0
St. Petersburg
Country [29] 0 0
Slovakia
State/province [29] 0 0
Dolny Kubin
Country [30] 0 0
Slovakia
State/province [30] 0 0
Kralovsky Chmlec
Country [31] 0 0
Slovakia
State/province [31] 0 0
Liptovsky Mikulas
Country [32] 0 0
Slovakia
State/province [32] 0 0
Povazska Bystrica
Country [33] 0 0
Slovakia
State/province [33] 0 0
Presov
Country [34] 0 0
Slovakia
State/province [34] 0 0
Trencin
Country [35] 0 0
Slovakia
State/province [35] 0 0
Vrable
Country [36] 0 0
Spain
State/province [36] 0 0
Badalona
Country [37] 0 0
Spain
State/province [37] 0 0
Barcelona
Country [38] 0 0
Spain
State/province [38] 0 0
Jerez de la Frontera (Cádiz)
Country [39] 0 0
Spain
State/province [39] 0 0
L'Hospitalet de Llobregat (Barcelona)
Country [40] 0 0
Spain
State/province [40] 0 0
Madrid
Country [41] 0 0
Spain
State/province [41] 0 0
Santa Coloma de Gramanet
Country [42] 0 0
Switzerland
State/province [42] 0 0
Gordola
Country [43] 0 0
Turkey
State/province [43] 0 0
Erzurum
Country [44] 0 0
Turkey
State/province [44] 0 0
Istanbul
Country [45] 0 0
Turkey
State/province [45] 0 0
Izmir
Country [46] 0 0
Ukraine
State/province [46] 0 0
Dnepropetrovsk
Country [47] 0 0
Ukraine
State/province [47] 0 0
Kharkov
Country [48] 0 0
Ukraine
State/province [48] 0 0
Kiev
Country [49] 0 0
Ukraine
State/province [49] 0 0
Lvov
Country [50] 0 0
Ukraine
State/province [50] 0 0
Odessa
Country [51] 0 0
Ukraine
State/province [51] 0 0
Zaporozhye
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Bexhill
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Blackpool
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Burbage, Hinkley
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Chestfield, Whitstable
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Chorley
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Edgbaston, Birmingham
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Ely
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Fowey
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Glasgow
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Penzance
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Plymouth
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Reading
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Saltash
Country [65] 0 0
United Kingdom
State/province [65] 0 0
St Stephen, St Austell
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Whitstable

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this trial is to demonstrate that the fixed dose combination of
telmisartan 40mg + amlodipine 10mg (T40/A10) or the fixed dose combination of telmisartan
80mg + amlodipine 10mg (T80/A10) is superior in reducing blood pressure at eight weeks
compared with amlodipine 10mg monotherapy (A10) in patients who fail to respond to six weeks
treatment with A10.
Trial website
https://clinicaltrials.gov/show/NCT00553267
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
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