|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00546052 |
Purpose
To determine if a one year treatment Losartan with or without HCTZ at different dosages have an effect on metabolic parameters in patients with hypertension and the metabolic syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension Metabolic Disorder |
Drug: losartan potassium (+) hydrochlorothiazide |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | 52 Week Study to Evaluate the Effects of LOSARTAN 50 mg, 100 mg, 100/12.5 mg HCTZ, 100/25 mg HCTZ on Metabolic Parameters, Blood Pressure and Safety in Hypertensive Patients With Metabolic Syndrome |
| Enrollment: | 1738 |
| Study Start Date: | September 2005 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Losartan (MK0954) / Losartan + HCTZ (MK0954A)
|
Drug: losartan potassium (+) hydrochlorothiazide
All patients received Losartan 50mg at Visit 2 titrated to Losartan 100mg (if target BP not achieved) titrated to Losartan 100mg + HCTZ 12.5mg (if necessary) up to Losartan 100mg + HCTZ 25mg. Duration of treatment was one year.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
An Adult Patient (At Least 18 Years Of Age) With A Clinical Identification Of The Metabolic Syndrome Using The IDF Definition:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_030, MK0954A-331 |
| Study First Received: | October 17, 2007 |
| Results First Received: | January 8, 2009 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00546052 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Losartan Metabolic Diseases Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Vascular Diseases Cardiovascular Agents Antihypertensive Agents |
Hydrochlorothiazide Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Anti-Arrhythmia Agents Hypertension |