A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension; Diabetes

Treatments: Drug: aliskiren

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219102

CSPP100A2310

Details and patient eligibility

About

To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide

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
• Uncontrolled diabetes type I and II
• 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