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

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ClinicalTrials.gov Identifier: NCT03259399
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : January 1, 2019
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

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.


Condition or disease Intervention/treatment
Enalapril Adverse Reaction Pharmacogenomics Stroke Genetic: detection of genotype

Study Type : Observational
Estimated Enrollment : 2200 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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.
Actual Study Start Date : August 16, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of dry cough [ Time Frame: At 2 years ]
  2. First Incidence of stroke [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese Patients:In accordance with anti-hypertension indications of enalapril
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259399


Contacts
Contact: Qian Xiang, Ph.D +86 010 66110802 xiangqz@126.com

Locations
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Qian Xiang, Ph.D    +86 010 66110802    xiangqz@126.com   
Sponsors and Collaborators
Cui Yimin

Responsible Party: Cui Yimin, Director of pharmacy,M.D & Ph.D, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03259399     History of Changes
Other Study ID Numbers: 2016[1238]
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: January 1, 2019
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Folic Acid
Vitamin B Complex
Enalapril
Enalaprilat
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents