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

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

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
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren




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, Older Adult)
Sexes Eligible for Study:   All
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00260923


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 Sponsor GmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov 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:
hypertension
aliskiren
blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases