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NCT00219102 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219102
Other study ID # CSPP100A2310
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2005
Est. completion date May 2007

Study information
Verified date February 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 336
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• aliskiren

Locations
Country Name City State
Belgium Investigative Site Kortrijk
Romania Investigative Site Bucharest
Spain Investigative Site Madrid
Sweden Investigative Site Stockholm
Switzerland Novartis Pharmaceuticals Basel
Ukraine Investigative Site Kiev
United States Investigative Site Salisbury North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Belgium,  Romania,  Spain,  Sweden,  Switzerland,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in diastolic blood pressure after 12 weeks
Secondary Change from baseline in systolic blood pressure after 12 weeks
Secondary Change from baseline in systolic and diastolic blood pressure after 6 weeks
Secondary Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
Secondary Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
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