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A Dose Ranging Study to Compare the Safety and Efficacy of Aliskiren 150mg, 300mg, and 600mg to Placebo 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.
ClinicalTrials.gov Identifier: NCT00219128
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Evaluate the blood pressure lowering effect of aliskiren 150mg, 300mg and 600mg compared to placebo in patients with essential hypertension

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 671 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Eight-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Comparing Aliskiren 150 mg, 300 mg, and 600 mg to Placebo in Patients With Essential Hypertension
Study Start Date : November 2004
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

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

Arms and Interventions


Outcome Measures

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 4 weeks and 8 weeks
  3. Blood pressure <140/90 mmHg after 4 weeks and 8 weeks
  4. Evaluate potential return of hypertension at 4 days and 2 weeks after 8 weeks
  5. Evaluate high and low level drug effect using 24 hour blood pressure monitoring

Eligibility Criteria

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
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

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): NCT00219128


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219128     History of Changes
Other Study ID Numbers: CSPP100A2308
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: June 2006

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, placebo

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases