Clinical Study to Evaluate Efficacy and Safety of Aliskiren (150mg & 300mg) Administered Alone and in Combo With Valsartan (160mg and 320mg) in Patients With High Blood Pressure

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00219180

First received: September 12, 2005

Last updated: November 7, 2011

Last verified: November 2011

History of Changes

Purpose

To evaluate the efficacy and safety of aliskiren alone and in combination with valsartan given to patients with essential hypertension

Condition	Intervention	Phase
Hypertension	Drug: aliskiren	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	An 8-week Multi-center, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren (150 mg and 300 mg) Administered Alone and in Combination With Valsartan (160 mg and 320 mg) in Patients With Hypertension

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 week 8

Secondary Outcome Measures:

Change from baseline in systolic blood pressure after week 8
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 4 and 8 weeks
Blood pressure control target of < 140/90 mmHg after 4 and 8 weeks
Evaluate 24-hour ambulatory blood pressure monitoring in a subset of patients

Enrollment:	1797
Study Start Date:	June 2005
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

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
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: NCT00219180

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 by Novartis

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

Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy and safety of combined use of aliskiren and valsartan in patients with hypertension: a randomised, double-blind trial. Lancet. 2007 Jul 21;370(9583):221-9.

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00219180 History of Changes
Other Study ID Numbers:	CSPP100A2327
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

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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