Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00157963
First received: September 7, 2005
Last updated: April 25, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine

Secondary Outcome Measures:
  • Safety/Tolerability

Enrollment: 174
Study Start Date: February 2005
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157963     History of Changes
Other Study ID Numbers: 0954A-314, 2005_067
Study First Received: September 7, 2005
Last Updated: April 25, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Losartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Calcium Channel Blockers
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 26, 2014