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

July 18, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Randomized Controlled Blind End Point Study of Enalapril Folic Acid Tablets Combined With Calcium Antagonist or Diuretic to Prevent Stroke in Patients With Type H Hypertension

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1.40-75 years old (inclusive);
  • 2. Patients who have been diagnosed with all types of essential hypertension (those who are currently taking antihypertensive drugs with normal blood pressure can still be admitted) or those whose blood pressure screening meets the inclusion criteria;
  • 3. Plasma (or serum) Hcy 10 mol/L;
  • 4. Enalapril folic acid tablet 10.8 mg/day alone is not up to standard;
  • 5. In the case of women of reproductive age, agree to use a reliable method of contraception during the trial;
  • 6. Participate voluntarily and sign the informed consent;

Exclusion Criteria:

  • 1. Previous stroke with definite diagnosis;
  • 2. Patients with previous well-diagnosed myocardial infarction;
  • 3. The presence of well-diagnosed heart failure;
  • 4. Postoperative revascularization;
  • 5.DBP >=110 mmHg or SBP >=180 mmHg;
  • 6. Confirmed secondary hypertension;
  • 7. Severe physical and systemic disease, which is estimated to be unable to complete the follow-up;
  • 8. People with known congenital or acquired organic heart disease;
  • 9. People who have had obvious intolerable adverse reactions to ACEI drugs in the past;
  • 10. Have contraindications to ACEI drugs (including renal failure) or are allergic to the drugs used in the study or other ingredients in the drugs;
  • 11. According to the researchers, there are contraindications to the use of folic acid;
  • 12. Pregnant and lactating women;
  • 13. 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;
  • 14. Unwilling to participate in the trial, unwilling or unable to change the existing medication regimen;
  • 15. Long-term use of folic acid or health medicines containing folic acid;
  • 16.Severe mental disorder, unable to express their will

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enalapril Folic Acid Tablets Combined With amlodipine
Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
Drug: Enalapril Folic Acid Tablets Combined With amlodipine
Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
Active Comparator: Enalapril Folic Acid Tablets Combined With hydrochlorothiazide
Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg
Drug: Enalapril Folic Acid Tablets Combined With hydrochlorothiazide
Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Stroke rate
Time Frame: Until 5 years
Until 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of combined end points of cardiovascular events
Time Frame: Until 5 years
Including cardiogenic death, cerebrovascular death, non-fatal stroke, and myocardial infarction
Until 5 years
Rate of all causes of death
Time Frame: Until 5 years
Including all causes and unexplained deaths
Until 5 years
Rate of first or recurrent ischemic stroke
Time Frame: Until 5 years
Until 5 years
Rate of first or recurrent hemorrhagic stroke
Time Frame: Until 5 years
Until 5 years
Rate of myocardial infarction
Time Frame: Until 5 years
Until 5 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Rate of heart failure (hospitalization)
Time Frame: Until 5 years
Until 5 years
Rate of coronary revascularization
Time Frame: Until 5 years
Until 5 years
Rate of peripheral arterial revascularization
Time Frame: Until 5 years
Until 5 years
Rate of malignant tumor
Time Frame: Until 5 years
Until 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Clinical Research Center, Southern Medical University
Ningbo Yinzhou Community Health Service Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jian-an Wang, Second Affiliated Hospital of Zhejiang University, School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014-132

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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