NCT01089452

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.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Monash University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Perindopril	Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
DRUG	Perindopril/amlodipine	Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.
DRUG	Olmesartan/amlodipine	Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.

Timeline

• First posted: 2010-03-18
• Last updated: 2015-06-03

Locations

1 site across 1 country: Australia