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Efficacy and Safety of a Single-pill Fixed Combination of Sufficient Losartan/Hydrochlorothiazide in Chinese Hypertensive Patients

NCT03946514 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-30

No results posted yet for this study

Summary

1. Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
2. Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
3. Rationale: Angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) combined with thiazide diuretic (DIU), which is the preferred combination for most hypertension guidelines. However, the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination evaluated by ambulatory blood pressure are still lack of clinical evidence.
4. Objective: To evaluate the efficacy and safety of losartan 100 mg/hydrochlorothiazide 25 mg fixed combination for ambulatory blood pressure after 8 weeks therapy in patients over 18 years with grade 1 or 2 hypertension either newly diagnosed or with blood pressure not controlled with monotherapy.
5. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: losartan/hydrochlorothiazide single-pill fixed combination and amlodipine/hydrochlorothiazide.
6. Study population: Men and Women aged over 18 years (n=180) meeting the inclusion/exclusion criteria.
7. Randomization and treatment: Patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers, eligible patients will be randomly divided into two groups, taking losartan 100 mg/hydrochlorothiazide 25 mg fixed combination once a day or amlodipine besylate tablets (5 mg/tablet) + hydrochlorothiazide tablets (25 mg/tablet) once a day.
8. Follow up: 8 weeks.
9. Sample size: a total of 180 patients should be enrolled in the combination.
10. Timeline: After obtaining the approval of Ethics Committee of Ruijin Hospital in September 2018, recruitment will start. Patients enrollment will be performed between October 2018 to August 2024. All patients should be followed up before August 2024.

Conditions

Interventions

DRUG

losartan/hydrochlorothiazide

losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination

DRUG

amlodipine/hydrochlorothiazide

amlodipine besylate tablets (5 mg / tablet) + hydrochlorothiazide tablets (25 mg / tablet)

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946514 on ClinicalTrials.gov