A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren in Patients With High Blood Pressure

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. Identifier: NCT00260923
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Brief Summary:
This is a study for people diagnosed with hypertension to compare 3 doses (75 mg, 150 mg, and 300 mg) of an experimental product, aliskiren in comparison to a placebo. Each patient is in the study for 8 weeks

Condition or disease Intervention/treatment Phase
Hypertension Drug: aliskiren Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing an Eight-week Treatment of Aliskiren 75 mg, 150 mg and 300 mg to Placebo in Patients With Essential Hypertension
Study Start Date : November 2005
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren
U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure after 8 weeks
  2. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 8 weeks

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male and female outpatients 18 years of age and older
  • 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 inclusion/exclusion criteria may apply

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 identifier (NCT number): NCT00260923

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Investigative Centers, Germany
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Sponsor GmbH

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00260923     History of Changes
Other Study ID Numbers: CSPP100A2328
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
blood pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases