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

• ClinicalTrials.gov Identifier: NCT00170937
• Recruitment Status: Completed
• First Posted: September 15, 2005
• Last Update Posted: November 18, 2016
• Sponsor: Novartis
• Information provided by: Novartis

Tracking Information

• First Submitted Date: September 10, 2005
• First Posted Date: September 15, 2005
• Last Update Posted Date: November 18, 2016
• Study Start Date: November 2004
• Actual Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 1, 2006): Change from baseline in insulin sensitivity after 16 weeks
• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 1, 2006)

• 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

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• Official Title: A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention

Condition

• METABOLIC SYNDROME
• HYPERTENSION
• PRE-HYPERTENSION

• Intervention: Drug: valsartan plus hydrochlorothiazide
• Study Arms: Not Provided
• Publications *: Zappe DH, Sowers JR, Hsueh WA, Haffner SM, Deedwania PC, Fonseca VA, Keeling L, Sica DA. Metabolic and antihypertensive effects of combined angiotensin receptor blocker and diuretic therapy in prediabetic hypertensive patients with the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2008 Dec;10(12):894-903. doi: 10.1111/j.1751-7176.2008.00054.x.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 1, 2006): 507
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00170937
• Other Study ID Numbers: CVAL489A2426
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: Novartis
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

• PRS Account: Novartis
• Verification Date: November 2016