Enalapril Adverse ReactionNCT03259399
A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.
An observational study of Enalapril Adverse Reaction and Pharmacogenomics, run by Cui Yimin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enalapril Adverse Reaction, Pharmacogenomics, Stroke
- What is being tested?
- detection of genotype
- How many people
- 2,200 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2017to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese Patients:In accordance with anti-hypertension indications of enalapril
Who may be able to join
- Patients taking enalapril or enalapril-folic acid therapy
- Signed informed consent.
Who cannot join
- Patients not taking enalapril treated
- Intolerance or unwillingness to blood sample collection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Qian Xiang, Ph.D, +86 010 66110802, xiangqz@126.com
About this study
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.
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.
- Conditions
- Enalapril Adverse Reaction, Pharmacogenomics, Stroke
- Being tested
- detection of genotype
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of genotypeGenetic
detection of genotype by next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| wild genotype | Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril Receives: Genetic: detection of genotype | |
| mutant genotype | Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril Receives: Genetic: detection of genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dry cough
Measured: At 2 years
First Incidence of stroke
Measured: At 2 years
Secondary outcomes (1)
Genotype detected by next generation sequencing
Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing.
Measured: pre-dose of enalapril or enalapril-folic acid (Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start16 Aug 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Enalapril Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259399
- Sponsor's protocol ID
- 2016[1238]
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mu G, Xie Q, Liu Z, Zhang H, Meng X, Song J, Zhou S, Wang Z, Wang Z, Zhao X, Jiang J, Liao M, Bao J, Zhang F, Xiang Q, Cui Y. Identification of genetic biomarkers associated with pharmacokinetics and pharmacodynamics of apixaban in Chinese healthy volunteers. Expert Opin Drug Metab Toxicol. 2023 Jan;19(1):43-51. doi: 10.1080/17425255.2023.2184344. Epub 2023 Mar 3.
PubMed 36867504Mu G, Xiang Q, Zhang Z, Liu C, Zhang H, Liu Z, Pang X, Jiang J, Xie Q, Zhou S, Wang Z, Hu K, Wang Z, Jiang S, Qin X, Cui Y. PNPT1 and PCGF3 variants associated with angiotensin-converting enzyme inhibitor-induced cough: a nested case-control genome-wide study. Pharmacogenomics. 2020 Jun;21(9):601-614. doi: 10.2217/pgs-2019-0167. Epub 2020 May 13.
PubMed 32397904
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03259399
- Acronym / sponsor ID
- 2016[1238]
- Conditions
- Enalapril Adverse Reaction, Pharmacogenomics, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 23 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wild genotype | – | Genetic: detection of genotypeDetection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril |
| mutant genotype | – | Genetic: detection of genotypeDetection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese Patients:In accordance with anti-hypertension indications of enalapril
Key inclusion criteria (2 listed)
- Patients taking enalapril or enalapril-folic acid therapy
- Signed informed consent.
Key exclusion criteria (2 listed)
- Patients not taking enalapril treated
- Intolerance or unwillingness to blood sample collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| detection of genotypedetection of genotype by next generation sequencing | Genetic | mutant genotype, wild genotype |
Primary outcome
Incidence of dry cough
Time frame: At 2 years
First Incidence of stroke
Time frame: At 2 years
1 secondary outcome
Genotype detected by next generation sequencing
Time frame: pre-dose of enalapril or enalapril-folic acid (Baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 36867504Mu G, Xie Q, Liu Z, Zhang H, Meng X, Song J, Zhou S, Wang Z, Wang Z, Zhao X, Jiang J, Liao M, Bao J, Zhang F, Xiang Q, Cui Y. Identification of genetic biomarkers associated with pharmacokinetics and pharmacodynamics of apixaban in Chinese healthy volunteers. Expert Opin Drug Metab Toxicol. 2023 Jan;19(1):43-51. doi: 10.1080/17425255.2023.2184344. Epub 2023 Mar 3.
- Derived from this study: PubMed 32397904Mu G, Xiang Q, Zhang Z, Liu C, Zhang H, Liu Z, Pang X, Jiang J, Xie Q, Zhou S, Wang Z, Hu K, Wang Z, Jiang S, Qin X, Cui Y. PNPT1 and PCGF3 variants associated with angiotensin-converting enzyme inhibitor-induced cough: a nested case-control genome-wide study. Pharmacogenomics. 2020 Jun;21(9):601-614. doi: 10.2217/pgs-2019-0167. Epub 2020 May 13.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enalapril Adverse Reaction and Pharmacogenomics, run by Cui Yimin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Xiang, Ph.D (+86 010 66110802, xiangqz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dry cough (time frame: At 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259399, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.