Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study

This study has been completed.

First Received: September 7, 2005 Last Updated: February 2, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00157963

Purpose

An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in Korean patients with essential hypertension

Condition	Intervention	Phase
Essential Hypertension	Drug: MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12 Week, Open, Randomized, Parallel, Multicenter Study of Efficacy, Tolerability & Safety of Hydrochlorothiazide (+) Losartan Potassium Versus Amlodipine in Essential Hypertensive Patients.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Losartan Losartan potassium Potassium chloride

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine

Secondary Outcome Measures:

Safety/Tolerability

Estimated Enrollment:	176
Study Start Date:	February 2005

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients of age 20 70 75 with essential hypertension
SiDBP 90 ~ 114mmHg at V1 & V2

Exclusion Criteria:

Patient has known or suspected secondary hypertension
Patient has a history of malignant hypertension (SiSBP > 210mmHg)
Individuals has a known sensitivity or intolerance to HCTZ or any AIIAs, or any sulfonamide-derived drugs.
Patient has shown significant abnormal laboratory evaluations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157963

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2005_067
Study First Received:	September 7, 2005
Last Updated:	February 2, 2007
ClinicalTrials.gov Identifier:	NCT00157963 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Amlodipine
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010