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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00219102

Recruitment Status : Completed

First Posted : September 22, 2005

Last Update Posted : February 25, 2011

Sponsor:

Information provided by:

Novartis

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

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Enrollment :	336 participants
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 :	June 2005
Actual Primary Completion Date :	May 2007
Actual Study Completion Date :	May 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Hypertension

Drug Information available for: Hydrochlorothiazide Valsartan Aliskiren

U.S. FDA Resources

Arms and Interventions

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219102

Locations

Layout table for location information

United States, North Carolina
Investigative Site
Salisbury,, North Carolina, United States, 28144
Belgium
Investigative Site
Kortrijk, Belgium
Romania
Investigative Site
Bucharest, Romania
Spain
Investigative Site
Madrid, Spain
Sweden
Investigative Site
Stockholm, Sweden
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Ukraine
Investigative Site
Kiev, Ukraine

Sponsors and Collaborators

Novartis

Investigators

Layout table for investigator information

Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Drummond W, Sirenko YM, Ramos E, Baek I, Keefe DL. Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. Am J Cardiovasc Drugs. 2011 Oct 1;11(5):327-33. doi: 10.2165/11591970-000000000-00000.

Layout table for additonal information

ClinicalTrials.gov Identifier:	NCT00219102 History of Changes
Other Study ID Numbers:	CSPP100A2310
First Posted:	September 22, 2005 Key Record Dates
Last Update Posted:	February 25, 2011
Last Verified:	February 2011

Keywords provided by Novartis:


Hypertension, diabetes, aliskiren,	blood pressure, valsartan, hydrochlorothiazide

Additional relevant MeSH terms:

Layout table for MeSH terms

Hypertension Vascular Diseases Cardiovascular Diseases Valsartan Hydrochlorothiazide Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers	Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators

To Top