Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study - Full Text View

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

MedlinePlus related topics:

High Blood Pressure

ChemIDplus related topics:

Hydrochlorothiazide Losartan Losartan potassium Amlodipine Amlodipine besylate Potassium chloride

U.S. FDA Resources

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.

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

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

Study placed in the following topic categories:

Losartan

Vascular Diseases

Essential hypertension

Angiotensin II

Hydrochlorothiazide

Amlodipine

Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Diuretics

Physiological Effects of Drugs

Sodium Chloride Symporter Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Membrane Transport Modulators

Angiotensin II Type 1 Receptor Blockers

Natriuretic Agents

Therapeutic Uses

Cardiovascular Diseases

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 10, 2008

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