- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089452
Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study (ACCESS)
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.
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.
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 group.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Alfred Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 18 years of age
- Has provided written informed consent
- 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 Patients with mild to moderate hypertension will be either de novo presenters with this condition or withdrawn from background antihypertensive therapy for a period of 2 weeks.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.
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
- Macroalbuminuria
- Current smoking (defined as smoking at least 7 cigarettes per week)
- Women must be post menopausal or using an acceptable method of contraception i.e. surgical sterilisation, hormonal contraception or double barrier method.
Exclusion Criteria:
- Secondary causes of hypertension (e.g. Conn's Syndrome, renal artery stenosis)
- Serum creatinine >0.25 mmol/L or eGFR <40 ml/min
- Serum potassium >5.5 mmol/L
- Abnormal LFTs (i.e. serum transaminases >2x ULN)
- Sitting SBP >180 mmHg
- Recent (<6 months) MI, CVA, TIA, revascularisation procedure
- Ethanol abuse (in the opinion of the investigator)
- Concomitant drug therapy that may impact on BP e.g. NSAIDs, COX-2 inhibitors, other antihypertensive agents
- Unable to comply with study requirements (in the opinion of the investigator)
- Pregnant or lactating women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Perindopril monotherapy
Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
|
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.
|
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.
|
Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood pressure between the groups
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute cardiovascular risk
Time Frame: 12 weeks
|
Measurements will be performed at baseline and 12 weeks of key variables that contribute to absolute cardiovascular risk.
|
12 weeks
|
Safety parameters
Time Frame: 12 weeks
|
Frequency of drug-related adverse events and major cardiovascular events.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Amlodipine
- Olmesartan
- Perindopril
Other Study ID Numbers
- CP-01/09
- HREC/10/Alfred/5 (Other Identifier: Consultative Council for Human Research Ethics)
- 62/10 (Other Identifier: Alfred Hospital)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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