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Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone

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: NCT00170989
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan plus hydrochlorothiazide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2714 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg
Study Start Date : September 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure from baseline after 8 weeks

Secondary Outcome Measures :
  1. Change from baseline in systolic blood pressure from baseline after 8 weeks
  2. Change from baseline in standing systolic and diastolic blood pressure after 8 weeks
  3. Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks
  4. Diastolic blood pressure less than 90 mmHg after 8 weeks
  5. Adverse events and serious adverse events at 8 weeks

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients with mild to moderate hypertension

Exclusion Criteria:

  • Severe hypertension
  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Contacts and Locations
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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): NCT00170989


Locations
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Germany
Investigative Centers, Germany
Switzerland
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00170989    
Other Study ID Numbers: CVAH631C2302
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: June 2006
Keywords provided by Novartis:
hypertension
high blood pressure
valsartan
hydrochlorothiazide
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Hydrochlorothiazide
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