Enalapril Folic Acid Tablets Combined With CCB or Diuretic to Prevent Stroke in Patients With Type H Hypertension

NCT04952051 | Completed Phase 3

• 1 other identifier: 2014-132
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension is a common condition that can cause serious events such as stroke, coronary heart disease and heart failure. Homocysteine (Hcy) is a substance in the body that is harmful to blood vessels. Hyperhomocysteinemia (plasma Hcy≥10 mol/L), which is associated with hypertension, significantly increases the risk of stroke. This type of high blood pressure is called type "H" hypertension. Enalapril folic acid tablet is an innovative drug developed independently in China and is the first choice for the treatment of H type hypertension. Patients with type H hypertension should be treated with enalapril folic acid tablets to reduce stroke. However, some patients had poor blood pressure control after monotherapy. At this time, other antihypertensive drugs should be used in combination. Amlodipine and Hydrochlorothiazide are the most commonly used and the best combination. The purpose of this study was to observe the difference in the efficacy of enalapril folic acid tablets in patients with uncontrolled blood pressure who were well tolerated and randomized to aminoclodipine or hydrochlorothiazide in reducing stroke and other cardiovascular and cerebrovascular events, and to explore the relationship between various alternative measures and efficacy.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Stroke rate

  Until 5 years

Secondary Outcomes (5)

• Rate of combined end points of cardiovascular events

  Until 5 years

• Rate of all causes of death

  Until 5 years

• Rate of first or recurrent ischemic stroke

  Until 5 years

• Rate of first or recurrent hemorrhagic stroke

  Until 5 years

• Rate of myocardial infarction

  Until 5 years

Other Outcomes (4)

• Rate of heart failure (hospitalization)

  Until 5 years

• Rate of coronary revascularization

  Until 5 years

• Rate of peripheral arterial revascularization

  Until 5 years

Study Arms (2)

Enalapril Folic Acid Tablets Combined With amlodipine

EXPERIMENTAL

Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg

Drug: Enalapril Folic Acid Tablets Combined With amlodipine

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

ACTIVE COMPARATOR

Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Drug: Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

Interventions

Enalapril Folic Acid Tablets Combined With amlodipine DRUG

Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg

Enalapril Folic Acid Tablets Combined With amlodipine

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide DRUG

Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (inclusive);
• \. Plasma (or serum) Hcy 10 mol/L;
• \. Enalapril folic acid tablet 10.8 mg/day alone is not up to standard;
• \. In the case of women of reproductive age, agree to use a reliable method of contraception during the trial;
• \. Participate voluntarily and sign the informed consent;

You may not qualify if:

• \. Previous stroke with definite diagnosis;
• \. Patients with previous well-diagnosed myocardial infarction;
• \. The presence of well-diagnosed heart failure;
• \. Postoperative revascularization;
• DBP \>=110 mmHg or SBP \>=180 mmHg;
• \. Confirmed secondary hypertension;
• \. Severe physical and systemic disease, which is estimated to be unable to complete the follow-up;
• \. People with known congenital or acquired organic heart disease;
• \. People who have had obvious intolerable adverse reactions to ACEI drugs in the past;
• \. Have contraindications to ACEI drugs (including renal failure) or are allergic to the drugs used in the study or other ingredients in the drugs;
• \. According to the researchers, there are contraindications to the use of folic acid;
• \. Pregnant and lactating women;
• \. If there are other obvious laboratory tests, abnormal physical signs and clinical diseases, it is not suitable to participate in the study according to the researcher's judgment;
• \. Unwilling to participate in the trial, unwilling or unable to change the existing medication regimen;
• \. Long-term use of folic acid or health medicines containing folic acid;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• National Clinical Research Center, Southern Medical University: collaborator
• Ningbo Yinzhou Community Health Service Center: collaborator

Study Sites (1)

Second affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Hypertension

Interventions

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 Officials

• Jian-an Wang

  Second Affiliated Hospital of Zhejiang University, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: July 7, 2021
• Study Start: July 1, 2014
• Primary Completion: July 31, 2019
• Study Completion: July 1, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-06

Locations

CN (1)