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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

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ClinicalTrials.gov Identifier: NCT00219115
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 7, 2017
Information provided by (Responsible Party):

Brief Summary:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 493 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in mean sitting systolic blood pressure after 8 weeks
  2. Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8
  3. Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
  4. Achieve mean sitting blood pressure control target of < 140/90 mmHg after 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

  • 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.

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): NCT00219115

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:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00219115     History of Changes
Other Study ID Numbers: CSPP100A2309
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists