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Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis (MK-0000-117)(Completed)

NCT00871871 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-07-28

Study results available
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Summary

This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).

Conditions

Interventions

DRUG

Hydrochlorothiazide (HCTZ)

HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.

DRUG

Comparator: Placebo to HCTZ

Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period

DRUG

Isosorbide mononitrate (ISMN)

ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period

DRUG

Comparator: Placebo to ISMN

Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-02-28
Completion
2010-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00871871 on ClinicalTrials.gov