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| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00871871 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: non-product or non-Merck product Drug: Comparator: Placebo to HCTZ Drug: Comparator: Isosorbide mononitrate (ISMN) Drug: Comparator: Placebo to ISMN |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Evaluate the Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis in Obese Patients With Hypertension |
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Part I, Arm 1: Experimental
Placebo in Period 1 followed by HCTZ in Period 2
|
Drug: non-product or non-Merck product
[Intervention Name: 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
|
|
Part I, Arm 2: Experimental
HCTZ in Period 1, followed by placebo in Period 2
|
Drug: non-product or non-Merck product
[Intervention Name: 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
|
|
Part II, Arm 1: Experimental
Placebo in Period 1, followed by ISMN in Period 2
|
Drug: Comparator: 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
|
|
Part II, Arm 2: Experimental
ISMN in Period 1, followed by placebo in Period 2
|
Drug: Comparator: 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
|
Eligibility| Ages Eligible for Study: | 35 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| South Africa, Gauteng | |
| MSD (Pty) LTD South Africa | Recruiting |
| Midrand, Gauteng, South Africa, 1685 | |
| Contact: Beverley Cowper 27 11 655-3036 | |
| Study Director: | Medical Monitor | Merck |
More Information
| Responsible Party: | Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2009_567, 117 |
| Study First Received: | March 27, 2009 |
| Last Updated: | January 27, 2010 |
| ClinicalTrials.gov Identifier: | NCT00871871 History of Changes |
| Health Authority: | South Africa: Medicines Control Council |
|
Isosorbide Vasodilator Agents Molecular Mechanisms of Pharmacological Action Isosorbide-5-mononitrate Diuretics, Osmotic Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Isosorbide Dinitrate |
Cardiovascular Agents Antihypertensive Agents Hydrochlorothiazide Pharmacologic Actions Nitric Oxide Donors Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Hypertension |