- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280540
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
November 5, 2010 updated by: Novartis
A 6-week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension
This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
648
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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East Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female age 18 or older
- Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)
Exclusion Criteria:
- Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
- History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
- History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Change from baseline systolic blood pressure after 4 weeks
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Change from baseline systolic blood pressure after 2 and 6 weeks
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Secondary Outcome Measures
Outcome Measure |
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Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
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Blood pressure less than 140/90 mmHg after 6 weeks
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Change from baseline diastolic blood pressure after 6 weeks
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Change from baseline in blood and urine markers after 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
January 19, 2006
First Submitted That Met QC Criteria
January 19, 2006
First Posted (Estimate)
January 23, 2006
Study Record Updates
Last Update Posted (Estimate)
November 9, 2010
Last Update Submitted That Met QC Criteria
November 5, 2010
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Sodium Chloride Symporter Inhibitors
- Valsartan
- Hydrochlorothiazide
Other Study ID Numbers
- CVAH631BUS05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
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Addpharma Inc.Completed
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Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
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Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
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Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
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Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
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Sheffield Teaching Hospitals NHS Foundation TrustUniversity of SheffieldCompletedIdiopathic Pulmonary Arterial Hypertension | Chronic Thromboembolic Pulmonary HypertensionUnited Kingdom
Clinical Trials on Valsartan/Hydrochlorothiazide
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NovartisCompleted
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NovartisCompletedHypertensionUnited States
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SanofiCompletedHypertensionIndia, Malaysia, Philippines, Singapore, Taiwan, Tunisia, Egypt, Korea, Republic of, Hong Kong, Indonesia, Morocco, Pakistan, Thailand, Vietnam
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Novartis PharmaceuticalsBaker Heart and Diabetes InstituteCompletedHypertensionUnited States, Australia
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Yonsei UniversityCompleted
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Damanhour UniversityCompletedHealthy Normotensive Participants
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NovartisCompletedHypertensionSwitzerland, Germany
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NovartisCompletedHypertensionSwitzerland, Germany