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Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension

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: NCT00387517
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : February 7, 2017
Information provided by:

Brief Summary:
The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren/HCTZ Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 726 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy
Study Start Date : October 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren

Primary Outcome Measures :
  1. Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.

Secondary Outcome Measures :
  1. Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
  2. Safety and tolerability
  3. Proportion of patients achieving a blood pressure control target at week 8

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
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female outpatients 18 years old or older.
  • Patients with a diagnosis of hypertension defined as follows:

    • Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= mmHg and < 110 mmHg at Visit 1.
    • All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP >= 85 mmHg and < 110 mmHg at Visit 2.
    • All patients must have a msDBP >= 90 mmHg and < 110 mmHg at Visit 5.
  • Patients who are eligible and consent to participate in the study

Exclusion Criteria:

  • Severe hypertension (msDBP >= 110 mmHg and/or MSSBP >=180 mmHg).
  • Previous or current diagnosis of heart failure.
  • History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
  • 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): NCT00387517

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United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Investigative Centers, Germany
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications of Results:
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Responsible Party: Novartis Identifier: NCT00387517    
Other Study ID Numbers: CSPP100A2333
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Novartis:
blood pressure
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases