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NOT YET RECRUITING
NCT05169021
PHASE4

Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

Summary

The primary objectives of this trial are: 1. Efficacy evaluation of amlodipine folic acid tablets: To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level. 2. Intensive Antihypertensive Therapy: To assess the effect of intensive antihypertensive therapy (SBP\<130 mmHg) versus standard antihypertensive therapy (SBP 130-\<140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.

Official title: Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, Blinded End-point Trial

Key Details

Gender

All

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15000

Start Date

2021-12-31

Completion Date

2028-12-31

Last Updated

2021-12-23

Healthy Volunteers

No

Interventions

DRUG

Amlodipine folic acid 5.8mg+intensive antihypertensive therapy

Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure(SBP\<130mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.

DRUG

Amlodipine folic acid 5.8mg+standard antihypertensive therapy

Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP:130-140mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.

DRUG

Amlodipine+intensive antihypertensive therapy

Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.

DRUG

Amlodipine+standard antihypertensive therapy

Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China