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Trial details imported from ClinicalTrials.gov
Ethics application status
Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study
ACCESS STUDY (Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study) ARB/CCB Combination Therapy: Efficacy vs an ACE-inhibitor/CCB Combination and Use as First Line Therapy.
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Drugs - Perindopril
Treatment: Drugs - Perindopril/amlodipine
Treatment: Drugs - Olmesartan/amlodipine
Active Comparator: Perindopril monotherapy - Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
Active Comparator: Perindopril/amlodipine - Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.
Experimental: Olmesartan/amlodipine FDC - Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.
Treatment: Drugs: Perindopril
Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
Treatment: Drugs: Perindopril/amlodipine
Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.
Treatment: Drugs: Olmesartan/amlodipine
Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.
Intervention code 
Comparator / control treatment
Primary outcome 
Change in blood pressure between the groups
Secondary outcome 
Absolute cardiovascular risk - Measurements will be performed at baseline and 12 weeks of key variables that contribute to absolute cardiovascular risk.
Secondary outcome 
Safety parameters - Frequency of drug-related adverse events and major cardiovascular events.
Key inclusion criteria
1. Over 18 years of age
2. Has provided written informed consent
3. Mild to moderate hypertension (WHO Stage 1-2). Patients with mild to moderate
hypertension will be either de novo presenters with this condition or withdrawn from
background antihypertensive therapy for a period of 2 weeks. If sSBP is not greater
than 140 mmHg after this 2 week withdrawal period (*130 mmHg if diabetes or CKD, as
per Heart Foundation of Australia Hypertension Guidelines 20082), patients can be
followed, off therapy, for a further 2 weeks in order to meet this criterion. If their
systolic blood pressure is above 180 mmHg they will be withdrawn from the study and
will be provided with appropriate treatment.
4. Hypertensive patients with a high level of risk, i.e. having at least one of the
following risk factors :
- History of CV event eg MI, stroke (>6 months ago)
- History of revascularization procedure (>6 months ago)
- Impaired kidney function (eGFR <70 ml/min)
- ECG or echocardiographic evidence of LV hypertrophy
- Obesity, defined as BMI >30 kg/m2
- Diabetes mellitus
- Peripheral arterial disease
- Current smoking (defined as smoking at least 7 cigarettes per week)
5. Women must be post menopausal or using an acceptable method of contraception i.e.
surgical sterilisation, hormonal contraception or double barrier method.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Secondary causes of hypertension (e.g. Conn's Syndrome, renal artery stenosis)
2. Serum creatinine >0.25 mmol/L or eGFR <40 ml/min
3. Serum potassium >5.5 mmol/L
4. Abnormal LFTs (i.e. serum transaminases >2x ULN)
5. Sitting SBP >180 mmHg
6. Recent (<6 months) MI, CVA, TIA, revascularisation procedure
7. Ethanol abuse (in the opinion of the investigator)
8. Concomitant drug therapy that may impact on BP e.g. NSAIDs, COX-2 inhibitors, other
9. Unable to comply with study requirements (in the opinion of the investigator)
10. Pregnant or lactating women
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
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
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Alfred Hospital - Melbourne
Recruitment postcode(s) 
Other collaborator category 
Ethics application status
This study is looking to evaluate which drug combination, olmesartan/amlodipine or
perindopril/amlodipine, is better at lowering blood pressure in people with mild to moderate
hypertension. The investigators will be enrolling people who are either currently taking
medication to lower their blood pressure or who have been recently diagnosed with high blood
pressure and are not yet on medication.
Patients on medication for their blood pressure will be asked to stop taking this medication
for 2 to 4 weeks. If their blood pressure is suitable (not too high or low) they will be
randomised to one of their treatment arm:
Group 1 will receive Perindopril on its own (5mg for 4 weeks followed by 10mg for 8 weeks).
There will be 80 patients in this group.
Group 2 will receive Perindopril and Amlodipine together (5mg/5mg for 4 weeks, 10mg/5mg for a
further 4 weeks then 10mg/10mg for the final 4 weeks). There will be 80 patient in this
Group 3 will receive Olmesartan and Amlodipine together (20mg/5mg for 4 weeks, 40mg/5mg for a
further 4 weeks then 40mg/10mg for the final 4 weeks). There will be 120 patients in this
During the study we will measure the patients blood pressure and heart rate, weight and
perform routine blood tests. They will also have ECGs (3 occasions) and 24 hour blood
pressure monitor (4 occasions).
At the end of the study patients pre-study medication will be restarted or they will be put
on to a suitable alternative.
Trial related presentations / publications
Henry Krum, MBBS FRACP PhD
Monash University / Alfred Hospital