Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00157963
First received: September 7, 2005
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  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:

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
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
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

ClinicalTrials.gov Identifier: NCT00157963     History of Changes
Other Study ID Numbers: 2005_067
Study First Received: September 7, 2005
Last Updated: May 23, 2013
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 June 17, 2013