Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension

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: NCT00273299
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE January 4, 2006
First Posted Date  ICMJE January 9, 2006
Last Update Posted Date November 8, 2011
Study Start Date  ICMJE November 2005
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
Blood pressure less than 140/90 mmHg after 4 weeks
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00273299 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
  • Blood pressure less than 140/90 mmHg after 6 weeks
  • Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
  • Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
  • Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
  • Adverse events and serious adverse events at each study visit for 6 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 Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
Official Title  ICMJE A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
Brief Summary The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
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
Intervention  ICMJE Drug: valsartan plus hydrochlorothiazide
Study Arms  ICMJE Not Provided
Publications * Calhoun DA, Glazer RD, Pettyjohn FS, Coenen PD, Zhao Y, Grosso A. Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Curr Med Res Opin. 2008 Aug;24(8):2303-11. doi: 10.1185/03007990802271946. Epub 2008 Jun 28.

*   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
Actual Enrollment  ICMJE
 (submitted: November 7, 2011)
607
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed severe hypertension

Exclusion Criteria:

  • Inability to discontinue all prior antihypertensive medications
  • Heart failure of any kind
  • History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
  • Diabetes with poor glucose control
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00273299
Other Study ID Numbers  ICMJE CVAH631D2301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals
PRS Account Novartis
Verification Date November 2011

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