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

Sponsor
Organon and Co (Industry)
Overall Status
Completed
CT.gov ID
NCT00157963
Collaborator
(none)
174
12.1

Study Details

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
  • Drug: MK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks
Phase 4

Study Design

Study Type:
Interventional
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 :
Feb 5, 2005
Actual Primary Completion Date :
Feb 8, 2006
Actual Study Completion Date :
Feb 8, 2006

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

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Organon and Co

Investigators

  • Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Organon and Co
ClinicalTrials.gov Identifier:
NCT00157963
Other Study ID Numbers:
  • 0954A-314
  • 2005_067
First Posted:
Sep 12, 2005
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022