Overview

Efficacy and Safety of Aliskiren 300 mg Compared to Telmisartan 80 mg After 1 Week of Treatment Withdrawal

Status:
Completed
Trial end date:
2010-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study was specifically designed to provide additional information on the mechanism of action of direct renin inhibition postulating the higher-level RAS cascade inhibition. The purpose of this study was to compare the prolonged efficacy and safety of aliskiren to that of telmisartan in mild to moderate hypertensive patients in the 24 hrs Ambulatory Blood Pressure Monitoring setting after a one week treatment withdrawal.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis
Treatments:
Telmisartan
Criteria
Inclusion Criteria:

- Mean sitting systolic blood pressure ≥ 140 mmHg and < 180 mmHg

- 24-hr mean ambulatory systolic blood pressure ≥ 135 mmHg

Exclusion Criteria:

- Severe hypertension defined as mean sitting systolic blood pressure ≥ 180 mmHg and/or
mean sitting diastolic blood pressure ≥ 110 mmHg

- Patients with Type 1 diabetes mellitus

- Secondary hypertension of any etiology

- Other protocol-defined inclusion/exclusion criteria may apply