A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00219193

First received: September 12, 2005

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Purpose

To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg

Resource links provided by NLM:

Drug Information available for: Valsartan Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures:

Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks
Change from baseline in standing blood pressure after 4 weeks and 8 weeks
Achieve blood pressure control target of < 140/90 mmHg after 8 weeks


Enrollment:	641
Study Start Date:	October 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Patients with essential hypertension
Patients who are eligible and able to participate in the study

Exclusion Criteria

Severe hypertension
History or evidence of a secondary form of hypertension

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219193

Locations


United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00219193 History of Changes
Other Study ID Numbers:	CSPP100A2331
Study First Received:	September 12, 2005
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:


Hypertension, aliskiren, blood pressure, valsartan, HCTZ

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Valsartan	Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 26, 2016

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