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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension, Diabetes Mellitus

Treatments: Drug: aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219089

CSPP100A2307

Details and patient eligibility

About

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

Enrollment: 839 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind