A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00219115
First received: September 12, 2005
Last updated: November 7, 2011
Last verified: June 2006

September 12, 2005
November 7, 2011
January 2005
March 2006   (final data collection date for primary outcome measure)
Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Not Provided
Complete list of historical versions of study NCT00219115 on ClinicalTrials.gov Archive Site
  • Change from baseline in mean sitting systolic blood pressure after 8 weeks
  • Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8
  • Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
  • Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8
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Not Provided
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A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg
A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg

To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.

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
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
493
March 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria

  • Patients with essential hypertension
  • Patients with body mass index ≥ 30 kg/m2

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 also apply.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00219115
CSPP100A2309
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2006

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