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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00157963
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : February 5, 2005
Primary Completion Date : February 8, 2006
Study Completion Date : February 8, 2006


Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Safety/Tolerability

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157963


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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00157963     History of Changes
Other Study ID Numbers: 0954A-314
2005_067
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

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