A Clinical Study to Compare an Aliskiren Based Hypertensive Regimen With a Ramipril Based One Followed by a Randomized Withdrawal.

Condition(s) targeted: Hypertension.

Intervention: aliskiren (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

To compare the aliskiren regimen versus the ramipril regimen on reduction in Blood Pressure.

Official title: A 26 Week, Double-Blind, Randomized, Multicenter, Parallel Group, Active-Controlled Study Comparing Aliskiren to Ramipril With Optional Addition of Hydrochlorothiazide, Followed by a 4 Week Double-Blind, Randomized, Placebo-Controlled Withdrawal in Patients With Essential Hypertension

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in diastolic blood pressure after 26 weeks

Secondary outcome:

Change from baseline in systolic blood pressure after 26 weeks

Change from baseline in diastolic blood pressure after 6 weeks and 12 weeks

Change from baseline in systolic blood pressure after 6 weeks and 12 weeks

Blood pressure control target of < 140/90 mmHg after 6, 12, and 26 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria

- Patients with essential hypertension

- Patients who are eligible and able to participate in the study

Exclusion Criteria

- Severe hypertension

- History or evidence of a secondary form of hypertension

- History of Hypertensive encephalopathy or cerebrovascular accident. Other

protocol-defined inclusion exclusion criteria also apply.

Novartis Pharmaceuticals, East Hanover, New Jersey, United States

Last updated: June 1, 2006