- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00170937
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome
November 16, 2016 updated by: Novartis
A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar.
Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases.
The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
507
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
-
-
New Jersey
-
E. Hanover, New Jersey, United States, 07936
- Novartis Pharmaceuticals
-
-
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
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Waist circumference: males > 40", females > 35 "
- MSSBP ≥ 130 mmHg but ≤ 160 mmHg and a MSDBP ≥ 85 mmHg but ≤ 100 mmHg
- At least one of the following criteria: - Fasting plasma glucose between 5.9 and 6.9 mmol/L; - Serum triglycerides > 150 mg/dL; - LDL Cholesterol: - < 40 mg/dL males; - < 50 mg/dL females
Exclusion Criteria:
- MSSBP> 180 mmHg or MSDBP > 110 mmHg
- Inability to discontinue all prior antihypertensives for a period of 4 weeks.
- History of diabetes
- History of stroke, transient ischemic attack or myocardial infarction.
- Significant weight change > 10 lbs during screening period
- Patients taking a diuretic for 3 months prior to screening.
Other protocol-defined 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline in insulin sensitivity after 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline in markers of inflammation and thrombosis after 16 weeks
|
Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
|
Change from baseline in lipid profile after 16 weeks
|
Change from baseline in a measurement of beta cell function after 16 weeks
|
Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 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
November 1, 2004
Primary Completion (Actual)
March 1, 2006
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Disease
- Hyperinsulinism
- Hypertension
- Syndrome
- Metabolic Syndrome
- Prehypertension
- Insulin Resistance
- 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
- CVAL489A2426
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.
Clinical Trials on METABOLIC SYNDROME
-
Universidad de los Andes, ChileCompleted
-
Mayo ClinicCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
Taipei Medical University WanFang HospitalUnknownMetabolic Cardiovascular SyndromeTaiwan
-
Charite University, Berlin, GermanyRecruitingMetabolic Syndrome, Protection AgainstGermany
-
Wageningen University and ResearchPhilips Healthcare; TNO; Friesland Campina; Albert Heijn; Menzis; Smart with food; Vi... and other collaboratorsCompletedMetabolic Syndrome, Protection AgainstNetherlands
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
University of HohenheimGerman Federal Ministry of Education and ResearchCompleted
-
Cairo UniversityCompletedMetabolic Syndrome in WomenEgypt
-
Andalas UniversityHasanuddin University; Universitas Sumatera UtaraCompletedMetabolic Syndrome, Protection AgainstIndonesia
Clinical Trials on valsartan plus hydrochlorothiazide
-
NovartisCompletedHypertensionSwitzerland, Germany
-
NovartisCompletedHypertensionUnited States
-
NovartisCompletedHypertensionSwitzerland, Germany
-
NovartisCompleted
-
NovartisCompletedHypertensionUnited States
-
NovartisCompleted
-
NovartisCompletedHypertensionUnited States
-
SanofiCompletedHypertensionIndia, Malaysia, Philippines, Singapore, Taiwan, Tunisia, Egypt, Korea, Republic of, Hong Kong, Indonesia, Morocco, Pakistan, Thailand, Vietnam
-
Novartis PharmaceuticalsBaker Heart and Diabetes InstituteCompletedHypertensionUnited States, Australia