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.

First Received: September 12, 2005 Last Updated: February 13, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00219193

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 III

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

MedlinePlus related topics: High Blood Pressure

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

Estimated Enrollment:	624
Study Start Date:	October 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 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

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

More Information

No publications provided

Study ID Numbers:	CSPP100A2331
Study First Received:	September 12, 2005
Last Updated:	February 13, 2007
ClinicalTrials.gov Identifier:	NCT00219193 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, aliskiren, blood pressure, valsartan, HCTZ

Study placed in the following topic categories:

Essential Hypertension
Vascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Valsartan
Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Agents

Antihypertensive Agents
Pharmacologic Actions
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009