A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.

August 27, 2019 updated by: Cui Yimin

A Study of Genetic Variants Associated With Enalapril-Induced Adverse Drug Reaction and Impact of Pharmacogenomics on First Stroke in Hypertensive Patients Taking Enalapril or Enalapril-Folic Acid Therapy.

Dry cough is the most common adverse reaction of angiotensin converting enzyme, including enalapril, in Chinese population. Clinical observations suggest that the incidence of ACEI-induced dry cough is different between Chinese and other racial groups, however, there is still lack of research data in Chinese. Stroke is the second leading cause of death in the world and leading cause of death in China. Except the known risk factor such as hypertension, high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored.

In this study, we will investigate whether there are specific genotypes which may predict the incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for developing guidelines on precision medication in enalapril therapy apply to Chinese population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2200

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
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chinese Patients:In accordance with anti-hypertension indications of enalapril

Description

Inclusion Criteria:

  • Patients taking enalapril or enalapril-folic acid therapy
  • Signed informed consent.

Exclusion Criteria:

  • Patients not taking enalapril treated
  • Intolerance or unwillingness to blood sample collection.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
wild genotype
Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril
Genetic: detection of genotype
detection of genotype by next generation sequencing
mutant genotype
Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril
Genetic: detection of genotype
detection of genotype by next generation sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dry cough
Time Frame: At 2 years
At 2 years
First Incidence of stroke
Time Frame: At 2 years
At 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genotype detected by next generation sequencing
Time Frame: pre-dose of enalapril or enalapril-folic acid (Baseline)
Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.
pre-dose of enalapril or enalapril-folic acid (Baseline)

Collaborators and Investigators

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

Sponsor

Cui Yimin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 16, 2017

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

August 21, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 23, 2017

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016[1238]

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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