HypertensionPhase 3NCT04952051

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

A Phase 3 study testing Enalapril Folic Acid Tablets Combined With amlodipine and Enalapril Folic Acid Tablets Combined With hydrochlorothiazide in people with Hypertension, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Hypertension
What is being tested?: Enalapril Folic Acid Tablets Combined With amlodipine and Enalapril Folic Acid Tablets Combined With hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,000 participants
Where: 1 siteChina
Study dates: 1 Jul 2014to 1 Jul 2020
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

China1 site

Second affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009

Other trials in China

About this study

Official title: 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.

Conditions: Hypertension
Being tested: Enalapril Folic Acid Tablets Combined With amlodipine, Enalapril Folic Acid Tablets Combined With hydrochlorothiazide
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enalapril Folic Acid Tablets Combined With amlodipineDrug
Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
Enalapril Folic Acid Tablets Combined With hydrochlorothiazideDrug
Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Study groups in NCT04952051
Study group	Role	What they receive
Enalapril Folic Acid Tablets Combined With amlodipine	Experimental	Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg Receives: 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 Receives: Drug: Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

What is being measured

The primary outcome is the main question the study is designed to answer.

Stroke rate
Measured: Until 5 years

Secondary outcomes (5)

Rate of combined end points of cardiovascular events
Including cardiogenic death, cerebrovascular death, non-fatal stroke, and myocardial infarction
Measured: Until 5 years
Rate of all causes of death
Including all causes and unexplained deaths
Measured: Until 5 years
Rate of first or recurrent ischemic stroke
Measured: Until 5 years
Rate of first or recurrent hemorrhagic stroke
Measured: Until 5 years
Rate of myocardial infarction
Measured: Until 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20141 Jul 2020

First posted7 Jul 2021
Study start1 Jul 2014
Primary completion31 Jul 2019
Study completion1 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,000 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04952051
Sponsor's protocol ID: 2014-132
Status last verified: Jun 2021
First submitted: 20 Jun 2021
Last updated: 23 Jul 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04952051
Acronym / sponsor ID: 2014-132
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,000 participants (actual)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Collaborators: National Clinical Research Center, Southern Medical University, Ningbo Yinzhou Community Health Service Center
Study start: 1 Jul 2014 (actual)
Primary completion: 31 Jul 2019 (actual)
Study completion: 1 Jul 2020 (actual)
First posted: 7 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Enalapril Folic Acid Tablets Combined With amlodipine	Experimental	Drug: Enalapril Folic Acid Tablets Combined With amlodipineEnalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
Enalapril Folic Acid Tablets Combined With hydrochlorothiazide	Active comparator	Drug: Enalapril Folic Acid Tablets Combined With hydrochlorothiazideEnalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enalapril Folic Acid Tablets Combined With amlodipineEnalapril 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 hydrochlorothiazideEnalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg	Drug	Enalapril Folic Acid Tablets Combined With hydrochlorothiazide

Primary outcome

Stroke rate
Time frame: Until 5 years

5 secondary outcomes

Rate of combined end points of cardiovascular events
Time frame: Until 5 years
Rate of all causes of death
Time frame: Until 5 years
Rate of first or recurrent ischemic stroke
Time frame: Until 5 years
Rate of first or recurrent hemorrhagic stroke
Time frame: Until 5 years
Rate of myocardial infarction
Time frame: Until 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.

Related trials for Hypertension

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Chronic Kidney Disease, Hypertension (HTN)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian-an Wang study chair

Second Affiliated Hospital of Zhejiang University, School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke rate (time frame: Until 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04952051.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.