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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00387517
First received: October 11, 2006
Last updated: July 16, 2008
Last verified: July 2008
History of Changes

October 11, 2006
July 16, 2008
October 2006
August 2007   (final data collection date for primary outcome measure)
Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.
Same as current
Complete list of historical versions of study NCT00387517 on ClinicalTrials.gov Archive Site
  • Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
  • Safety and tolerability
  • Proportion of patients achieving a blood pressure control target at week 8
Same as current
Not Provided
Not Provided
 
Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: Aliskiren/HCTZ
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
726
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00387517
CSPP100A2333
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP