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 |
---|---|---|
|
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
- Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine []
Secondary Outcome Measures
- 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