Status:
UNKNOWN
H-Type Hypertension Precision Medicine Trial
Lead Sponsor:
Shenzhen Ausa Pharmed Co.,Ltd
Collaborating Sponsors:
Second Affiliated Hospital of Nanchang University
Shenzhen Evergreen Medical Institute
Conditions:
Hypertension
Eligibility:
All Genders
45+ years
Phase:
PHASE4
Brief Summary
This is a multicenter, randomized, double-blind, controlled clinical trial. It aims to investigate the effects of different doses of folic acid on lowering homocysteine (Hcy) in patients with hyperten...
Detailed Description
Phase I: Screening（V0） Phase I takes place for about 2-10 days. The purpose is to obtain informed consent and make a preliminary assessment of the patient. At the first screening visit (V0), or prio...
Eligibility Criteria
Inclusion
- Inclusion Criteria for run-in period:
- （1）≥ 45 years old;
- （2）A diagnosis or previous diagnosis of essential hypertension, including anyone currently taking antihypertensive drugs; or for those who have not taken antihypertensive drugs within the last 2 weeks, two consecutive examinations were conducted at least one day apart, and both sitting blood pressure (mean value of 3 measurements) met the following criteria: diastolic blood pressure (DBP) ≥90 mmHg or systolic blood pressure (SBP) ≥140 mmHg (the second blood pressure was measured at V1);
- （3）If a study participant is a woman of childbearing age, she agrees to use a reliable contraceptive method during the trial;
- （4）Voluntarily participates and has signed an informed consent form.
- Inclusion Criteria for Double-Blind Treatment Period:
- （1）Completed MTHFR C677T gene polymorphism detection in run-in period or MTHFR C677T genotype already known in advance;
- （2）Exhibited good tolerance to enalapril and good overall medication compliance (\>80%) in run-in period or previously exhibited good tolerance and adherence to ACEI drugs in previous medication history.
- （3）Voluntarily continues to participate in this study.
- Exclusion Criteria:
- Participants meeting any of the following criteria may not participate in this study:
- （1）Women who are pregnant and/or lactating; or women who intend to conceive within a year;
- （2）History of allergies to enalapril, folic acid or other components of the compound drug;
- （3）History of adverse reactions or intolerance to enalapril or other ACE inhibitors, or drugs or supplements containing folic acid;
- （4）Diagnosis or suspicion of secondary hypertension;
- （5）Known serious medical conditions, including: Cardiovascular: patients with clinically diagnosed cardiac dysfunction (NYHA class III and above), hypertrophic obstructive cardiomyopathy, clinically significant valvular heart disease, acute coronary syndrome within the last 3 months, or percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG); or abnormal pre-enrollment ECG test results with clinically significant arrhythmias (atrial flutter, atrial fibrillation, grade II-III atrioventricular block, etc.); Digestive: a previous diagnosis of various types of viral hepatitis that are still in the active phase; abnormal pre-enrollment liver function test results (ALT, AST, GGT, TBIL, or DBIL 3 times higher than normal, ALB ≤ 30g/L); gastrectomy and/or gastrojejunostomy; gastrointestinal dysfunction; Urinary: pre-enrollment serum creatinine greater than 200μmol/L; clinical diagnosis of renal artery stenosis, isolated kidney, kidney transplantation and/or other diseases; Endocrine: type 1 diabetes or uncontrolled type 2 diabetes (fasting blood glucose above 11.1 mmol/L at pre-enrollment); previous diagnosis of hyperthyroidism and failure to correct; Respiratory: pulmonary heart disease; chronic obstructive pulmonary disease; Neuropsychiatric: recent transient ischemic attack or stroke (within the last 3 months); peripheral or severe autonomic dysfunction; mental or nervous system dysfunction, inability to express desire; known drug or alcohol dependence; Malignancy, malnutrition, hematopoietic disorders and other serious diseases.
- （6）Significant signs of abnormalities as seen in laboratory tests or physical characteristics, which, at the discretion of the investigators, indicates that the patient is experiencing a serious illness or, may affect the observation and evaluation of the drug's efficacy or adverse events, or renders the patient unsuitable for participating in this study;
- （7）Patients currently taking folate, B12, or B6, or any compounds containing them, who express an inability or a refusal to stop usage;
- （8）Regular usage of folic acid supplements or compounds containing folic acid in the past 3 months;
- （9）Participation in a clinical trial for a drug that has not yet been officially approved for marketing within one month prior to the first visit.
Exclusion
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
3600 Patients enrolled
Trial Details
Trial ID
NCT03472508
Start Date
March 20 2018
End Date
June 30 2019
Last Update
July 18 2018
Active Locations (5)
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1
Anqing Research Center of Anhui Medical University Biomedical Institute
Anqing, Anhui, China
2
Peking University First Hosptial
Beijing, China
3
The First People's Hospital of Lianyungang
Lianyungang, China
4
Second Affiliated Hospital of Nanchang University
Nanchang, China