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Trial record 29 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

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.
 
ClinicalTrials.gov Identifier: NCT00219102
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : February 25, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date February 25, 2011
Study Start Date  ICMJE June 2005
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
Change from baseline in diastolic blood pressure after 12 weeks
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00219102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate Safety & Efficacy of the Combination of Aliskiren, Valsartan & Hydrochlorothiazide in Diabetic Hypertensive Nonresponder Patients
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Diabetes
Intervention  ICMJE Drug: aliskiren
Study Arms  ICMJE Not Provided
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 1, 2006)
336
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Romania,   Spain,   Sweden,   Switzerland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00219102
Other Study ID Numbers  ICMJE CSPP100A2310
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2011

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