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

NCT03946514 | Completed Phase 4 DMC

• 1 other identifier: FOCUS
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study name: Efficacy and safety of a single-pill fixed combination of sufficient losartan/hydrochlorothiazide in Chinese hypertensive patients (FOCUS)
2. 2.Medicine: Losartan 100 mg/hydrochlorothiazide 25 mg single-pill fixed combination; amlodipine besylate tablet (5 mg/tablet); hydrochlorothiazide tablets (25 mg/tablet)
3. 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. 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. 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. 6.Study population: Men and Women aged over 18 years (n=180) meeting the inclusion/exclusion criteria.
7. 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. 8.Follow up: 8 weeks.
9. 9.Sample size: a total of 180 patients should be enrolled in the combination.
10. 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

Hypertension

Keywords

Blood pressure; single-pill fixed combination; losartan/hydrochlorothiazide; amlodipine/hydrochlorothiazide

Outcome Measures

Primary Outcomes (2)

• Adverse events

  Number of participants with treatment-related adverse events at the end of 8 weeks of follow-up

  8 weeks

• Blood pressure control rate

  The blood pressure controlled rate after 8 weeks of treatment

  8 weeks

Secondary Outcomes (1)

• Ambulatory blood pressure change

  8 weeks

Study Arms (2)

losartan/hydrochlorothiazide group

EXPERIMENTAL

Drug: losartan/hydrochlorothiazide

amlodipine/hydrochlorothiazide group

ACTIVE COMPARATOR

Drug: amlodipine/hydrochlorothiazide

Interventions

losartan/hydrochlorothiazide DRUG

losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination

losartan/hydrochlorothiazide group

amlodipine/hydrochlorothiazide DRUG

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

amlodipine/hydrochlorothiazide group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or Women aged between 18 years will be screened, who should never take antihypertensive drugs or stop antihypertensive drugs for more than 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg or who is on monotherapy for at least 2 weeks with systolic blood pressure of 140-179 mmHg and / or diastolic blood pressure of 90-109 mmHg will be screened. Before randomization, two visits should be performed and 6 clinic blood pressures should be recorded. The average of the 6 clinic blood pressures should be 140-179 mmHg in systolic and/or 90-109 mmHg in diastolic. Regardless of whether the office blood pressure meets the enrollment conditions, a one-week home blood pressure measurement should be performed before randomization. Patient should sign the written consent form before screening and be able to go to the clinic by him/herself.

You may not qualify if:

• suspected or confirmed secondary hypertension; history of coronary heart disease, myocardial infarction, heart failure, stroke or dementia; taking other drugs that might affect blood pressure; liver dysfunction, serum creatinine ≥1.5 mg/dL (133 μmol/L), urine protein positive; serum potassium \>5.5 mmol/L or \<3.5 mmol/L; history of gout or serum uric acid ≥420 μmol/L for man and ≥360 μmol/L for women; elderly care patients; or patients who are participating in other clinical trials.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai Institite of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

hydrochlorothiazide, losartan drug combination; Amlodipine; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Shanghai Institute of Hypertension

Model Details: 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.

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 10, 2019
• Study Start: September 1, 2018
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

CN (1)