A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

Condition(s) targeted: Hypertension, Diabetes Mellitus

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 demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

Official title: An Eight-Week, Randomized, Double-Blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus

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

Primary outcome: Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary outcome:

Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure

Change from baseline to week 8 endpoint in mean sitting systolic blood pressure

Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks

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

Criteria:

Inclusion Criteria

- Patients with essential hypertension

- Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.

- 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 exclusion criteria may apply

Investigative Centers, Germany

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: November 2004
Last updated: November 9, 2006