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

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.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03259399
Enrollment
2200
Registered
2017-08-23
Start date
2017-08-16
Completion date
2020-06-30
Last updated
2019-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enalapril Adverse Reaction, Pharmacogenomics, Stroke

Brief summary

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.

Interventions

detection of genotype by next generation sequencing

Sponsors

Cui Yimin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Incidence of dry coughAt 2 years
First Incidence of strokeAt 2 years

Secondary

MeasureTime frameDescription
Genotype detected by next generation sequencingpre-dose of enalapril or enalapril-folic acid (Baseline)Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.

Countries

China

Contacts

Primary ContactQian Xiang, Ph.D
xiangqz@126.com+86 010 66110802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026