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A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder 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: NCT00219102
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 11, 2020
Information provided by:

Brief Summary:
To evaluate the blood pressure lowering effect and safety of aliskiren used in combination with valsartan/hydrochlorothiazide in diabetic patients with essential hypertension, not adequately responsive to the combination of valsartan and hydrochlorothiazide

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 12-week, Randomized, Double-blind, Placebo Controlled, Parallel Group Study Evaluating the Efficacy & Safety of Aliskiren in Patients With Diabetes & Hypertension Not Adequately Responsive to the Combination of Valsartan 160 mg & Hydrochlorothiazide 25 mg
Study Start Date : June 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren

Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 12 weeks

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure after 12 weeks
  2. Change from baseline in systolic and diastolic blood pressure after 6 weeks
  3. Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
  4. Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks

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

  • Patients with essential hypertension
  • Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus.
  • Patients who are eligible and able to participate in the study

Exclusion Criteria

  • Severe hypertension
  • Uncontrolled diabetes type I and II
  • History or evidence of a secondary form of hypertension
  • History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined 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): NCT00219102

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United States, North Carolina
Investigative Site
Salisbury, North Carolina, United States, 28144
Investigative Site
Kortrijk, Belgium
Investigative Site
Bucharest, Romania
Investigative Site
Madrid, Spain
Investigative Site
Stockholm, Sweden
Novartis Pharmaceuticals
Basel, Switzerland
Investigative Site
Kiev, Ukraine
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00219102    
Other Study ID Numbers: CSPP100A2310
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2011
Keywords provided by Novartis:
blood pressure,
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases