H-Type Hypertension Precision Medicine Trial

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 hypertension with different genotypes of MTHFR C677T and to determine a dose-response relationship.

This study consists of 3 phases: screening ( 2-10 days ), run-in period (0-2 weeks), and double-blind treatment (8 weeks). Follow-up visits will take place at the beginning of both the run-in period and the double-blind treatment period, and at the end of the 2nd, 4th, 6th, and 8th weeks. Hypertensive patients demonstrating good tolerance and adherence to angiotensin converting enzyme inhibitor (ACEI) drugs and who have already been genotyped for MTHFR C677T polymorphism may pass over the run-in period and directly enter the double-blind randomized treatment period. No medications that could affect the assessment of efficacy may be taken during any stage of the study.

Conditions

• Hypertension

Interventions

DRUG

Folic Acid

Folic acid used in this study are listed products. All drugs used in the double-blind treatment period of this study will be loaded into safety capsules with the same outer appearance; all parties involved in the trial will be unaware of the contents of the capsules.

DRUG

Enalapril Maleate and Folic Acid Tablets (Yiye)

Enalapril Maleate and Folic Acid Tablets (Yiye) have been approved for listing by the China Food and Drug Administration. Approval number: Zhunzi H20103723.All drugs used in the double-blind treatment period of this study will be loaded into safety capsules with the same outer appearance; all parties involved in the trial will be unaware of the contents of the capsules.

DRUG

Enalapril

Enalapril used in this study are listed products. All drugs used in the double-blind treatment period of this study will be loaded into safety capsules with the same outer appearance; all parties involved in the trial will be unaware of the contents of the capsules.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• Shenzhen Evergreen Medical Institute

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• The First People's Hospital of Lianyungang

  collaborator OTHER

• People's Hospital of Rongcheng

  collaborator UNKNOWN

• Anqing Research Center of Anhui Medical University Biomedical Institute

  collaborator UNKNOWN

• Shenzhen Ausa Pharmed Co.,Ltd

  lead INDUSTRY

Principal Investigators

• Xiaoshu Cheng, MD · Second Affiliated Hospital of Nanchang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-20

Primary Completion

2019-03-30

Completion

2019-06-30

Countries

• China

Study Locations