Angiotensin Receptor Blocker Combined With Calcium Antagonist Evaluation of Safety and Lowering of Systolic Blood Pressure Study
Summary
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. We 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 Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Hypertension
Intervention
Perindopril, Perindopril/amlodipine, Olmesartan/amlodipine
Location
Alfred Hospital
Melbourne
Victoria
Australia
3004
Status
Not yet recruiting
Source
Monash University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01089452
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:15:06-0400
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Medical and Biotech [MESH] Definitions
Amlodipine Besylate, Olmesartan Medoxomil Drug Combination
A pharmaceutical preparation of amlodipine besylate and olmesartan medoxomil that combines ANGIOTENSIN II TYPE I RECEPTOR ANTAGONIST and CALCIUM CHANNEL BLOCKER activities. It is used in the management of HYPERTENSION.
Amlodipine, Valsartan Drug Combination
A pharmaceutical preparation of amlodipine and valsartan that is used for the treatment of HYPERTENSION.
Perindopril
An angiotensin-converting enzyme inhibitor. It is used in patients with hypertension and heart failure.
Amlodipine
A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.
Olmesartan Medoxomil
An ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to manage HYPERTENSION.
