A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00219102
First received: September 12, 2005
Last updated: February 24, 2011
Last verified: February 2011

September 12, 2005
February 24, 2011
June 2005
May 2007   (final data collection date for primary outcome measure)
Change from baseline in diastolic blood pressure after 12 weeks
Not Provided
Complete list of historical versions of study NCT00219102 on ClinicalTrials.gov Archive Site
  • Change from baseline in systolic blood pressure after 12 weeks
  • Change from baseline in systolic and diastolic blood pressure after 6 weeks
  • Diastolic blood pressure of < 80 mmHg or a reduction from baseline of diastolic blood pressure of > 10 mmHg after 12 weeks
  • Achieve mean sitting blood pressure control target of < 130/80 mmHg after 12 weeks
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A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Hypertension
  • Diabetes
Drug: aliskiren
Not Provided
Drummond W, Sirenko YM, Ramos E, Baek I, Keefe DL. Aliskiren as add-on therapy in the treatment of hypertensive diabetic patients inadequately controlled with valsartan/HCT combination: a placebo-controlled study. Am J Cardiovasc Drugs. 2011 Oct 1;11(5):327-33. doi: 10.2165/11591970-000000000-00000.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
336
May 2007
May 2007   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Romania,   Spain,   Sweden,   Ukraine,   Switzerland
 
NCT00219102
CSPP100A2310
Not Provided
Not Provided
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2011

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