A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

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: NCT00386139
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):

Brief Summary:
Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 881 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 (300/12.5 mg and 300/25 mg) in Comparison With Aliskiren 300 mg in Patients With Essential Hypertension Not Adequately Responsive to Aliskiren 300 mg Monotherapy
Study Start Date : September 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

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

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, Senior)
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.
  • Patients who are eligible and consent to participate in the study

Exclusion Criteria:

  • Severe hypertension
  • Previous or current diagnosis of heart failure.
  • History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
  • 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): NCT00386139

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

Additional Information:
Publications of Results:
Responsible Party: Novartis Identifier: NCT00386139     History of Changes
Other Study ID Numbers: CSPP100A2332
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Novartis:
blood pressure
hydrochlorothiazide, HCTZ

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action