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

A 12 Week, Open, Randomized, Parallel, Multicenter Study of Efficacy, Tolerability & Safety of Hydrochlorothiazide (+) Losartan Potassium Versus Amlodipine in Essential Hypertensive Patients.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157963

Enrollment

174

Registered

2005-09-12

Start date

2005-02-05

Completion date

2006-02-08

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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

Interventions

DRUGMK0954A; hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Antihypertensive efficacy of 12 weeks of treatment with hydrochlorothiazide (+) losartan potassium/amlodipine	—

Secondary

Measure	Time frame
Safety/Tolerability	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026