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

This study has been completed.

First Received: September 12, 2005 Last Updated: January 9, 2008 History of Changes

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219102

Purpose

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	Intervention	Phase
Hypertension Diabetes	Drug: aliskiren	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Hydrochlorothiazide Valsartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

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

Estimated Enrollment:	336
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219102

Locations

Switzerland
Novartis Pharmaceuticals
Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CSPP100A2310
Study First Received:	September 12, 2005
Last Updated:	January 9, 2008
ClinicalTrials.gov Identifier:	NCT00219102 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension,
diabetes,
aliskiren,

blood pressure,
valsartan,
hydrochlorothiazide

Additional relevant MeSH terms:

Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Diuretics
Physiological Effects of Drugs
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Glucose Metabolism Disorders
Valsartan
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010