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 - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 13, 2006

Start Date ^ICMJE

June 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Change from baseline in diastolic blood pressure after week 8

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00219180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: aliskiren

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1784

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Germany

Administrative Information

NCT ID ^ICMJE

NCT00219180

Responsible Party

Study ID Numbers ^ICMJE

CSPP100A2327

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

September 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP