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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00219102

Collaborator

(none)

336

Enrollment

Locations

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension Diabetes	Drug: aliskiren	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Change from baseline in diastolic blood pressure after 12 weeks []

Secondary Outcome Measures

Change from baseline in systolic blood pressure after 12 weeks []
Change from baseline in systolic and diastolic blood pressure after 6 weeks []
Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks []
Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Salisbury	North Carolina	United States	28144
2	Investigative Site	Kortrijk		Belgium
3	Investigative Site	Bucharest		Romania
4	Investigative Site	Madrid		Spain
5	Investigative Site	Stockholm		Sweden
6	Novartis Pharmaceuticals	Basel		Switzerland
7	Investigative Site	Kiev		Ukraine