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Trial record 8 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With 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: NCT00277472
Recruitment Status : Completed
First Posted : January 16, 2006
Last Update Posted : June 7, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan/Hydrochlorothiazide Drug: HCTZ Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy
Study Start Date : November 2005
Actual Primary Completion Date : November 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: valsartan HCTZ Drug: Valsartan/Hydrochlorothiazide
160/12.5 mg taken once daily orally
Other Name: Co-Diovan, Diovan HCT

Active Comparator: HCTZ Drug: HCTZ
25 mg taken once daily orally
Other Name: hydrochlorothiazice, water pill




Primary Outcome Measures :
  1. Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
  2. Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure after 2 weeks and 4 weeks
  2. Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks
  3. Change in systolic blood pressure at 20 weeks compared to 4 weeks
  4. Change in diastolic blood pressure at 20 weeks compared to 4 weeks


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female 18 years of age and older
  • Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg

Exclusion Criteria:

  • - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
  • Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
  • History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.

Other protocol-defined inclusion/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 ClinicalTrials.gov identifier (NCT number): NCT00277472


Locations
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United States, New Jersey
Novartis
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis 862-778-8300 Pharmaceuticals Novartis

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Responsible Party: Study Director, Novartis Pharma
ClinicalTrials.gov Identifier: NCT00277472     History of Changes
Other Study ID Numbers: CVAH631BUS04
First Posted: January 16, 2006    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: March 2008
Keywords provided by Novartis:
Hypertension
High blood pressure
diuretics
valsartan
Additional relevant MeSH terms:
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Valsartan
Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators