Essential HypertensionPhase 4NCT01629225
GRK4 Polymorphisms Blood Pressure Response to Candesartan
A Phase 4 study testing Candesartan in people with Essential Hypertension, run by Third Military Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the association between GRK4 polymorphisms and essential hypertension in southwestern Han Chinese and test whether these polymorphisms were associated with the changes in blood pressure in patients with essential hypertension treated with angiotensin II Type antagonist… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Candesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Jul 2013to Jul 2015
- Phase
- Phase 4
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women with mild to moderate essential hypertension in southwestern Han Chinese
Who cannot join
- subjects unwilling to participate or subjects did not have all measurement required,
- subjects who were on medications, which affect blood pressure or
- whose DNA failed to amplify and 8 with errors in Mendelian segregation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Daping Hospital, The Third Military Medical University
Chongqing, 400042
Yu Changqing, MD, changqingyu-2@163.com
About this study
The purpose of this study is to investigate the association between GRK4 polymorphisms and essential hypertension in southwestern Han Chinese and test whether these polymorphisms were associated with the changes in blood pressure in patients with essential hypertension treated with angiotensin II Type antagonist candesartan.
Read the detailed description
All antihypertensive agents were withdrawn before the start of a 4-6 week, single-blind, after which the patients received candesartan 10 mg or 20mg once daily as monotherapy in a single-blind fashion. The doses were doubled after 1 weeks if DBP was ≥ 90 mmHg.
- Conditions
- Essential Hypertension
- Being tested
- Candesartan
- Keywords
- men and women, in southwestern Han Chinese
- Medical subject headings
- Essential Hypertension, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Also called GRK4 polymorphisms and essential hypertrension
To investigate the response to candesartan among southwestern Han Chinese with essential hypertrension
| Study group | Role | What they receive |
|---|---|---|
| candesartan | No intervention | All antihypertensive agents were withdrawn before the start of a 4-6 week, single-blind, after which the patients received candesartan 10 mg or 20 mg once daily as monotherapy in a single-blind fashion. The doses were doubled after 1 weeks if DBP was ≥90 mmHg. Receives: Drug: Candesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The subjects with GRK4 varirants may exert different response during 4 weeks of treatment with candesartan in patients with essential hypertension
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startJul 2013
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (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 Essential HypertensionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Changqing, Third Military Medical University
- Investigators
- Zeng Chunyu, Doctor, Study director, TMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629225
- Sponsor's protocol ID
- ThirdMMU
- Status last verified
- Jun 2013
- First submitted
- 24 Jun 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cai Y, Yang Y, Chen X, He D, Zhang X, Wen X, Hu J, Fu C, Qiu D, Jose PA, Zeng C, Zhou L. Circulating "LncPPARdelta" From Monocytes as a Novel Biomarker for Coronary Artery Diseases. Medicine (Baltimore). 2016 Feb;95(6):e2360. doi: 10.1097/MD.0000000000002360.
PubMed 26871769Yang Y, Cai Y, Wu G, Chen X, Liu Y, Wang X, Yu J, Li C, Chen X, Jose PA, Zhou L, Zeng C. Plasma long non-coding RNA, CoroMarker, a novel biomarker for diagnosis of coronary artery disease. Clin Sci (Lond). 2015 Oct 1;129(8):675-85. doi: 10.1042/CS20150121. Epub 2015 Jun 11.
PubMed 26201019
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRK4 Polymorphisms Blood Pressure Response to Candesartan
- ClinicalTrials.gov ID
- NCT01629225
- Acronym / sponsor ID
- ThirdMMU
- Conditions
- Essential Hypertension
- Keywords
- men and women, in southwestern Han Chinese
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 27 Jun 2012 (estimated)
- 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.
The purpose of this study is to investigate the association between GRK4 polymorphisms and essential hypertension in southwestern Han Chinese and test whether these polymorphisms were associated with the changes in blood pressure in patients with essential hypertension treated with angiotensin II Type antagonist candesartan.
Detailed description
All antihypertensive agents were withdrawn before the start of a 4-6 week, single-blind, after which the patients received candesartan 10 mg or 20mg once daily as monotherapy in a single-blind fashion. The doses were doubled after 1 weeks if DBP was ≥ 90 mmHg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| candesartan | No intervention | Drug: CandesartanAll antihypertensive agents were withdrawn before the start of a 4-6 week, single-blind, after which the patients received candesartan 10 mg or 20 mg once daily as monotherapy in a single-blind fashion. The doses were doubled after 1 weeks if DBP was ≥90 mmHg. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- men and women with mild to moderate essential hypertension in southwestern Han Chinese
Key exclusion criteria (3 listed)
- subjects unwilling to participate or subjects did not have all measurement required,
- subjects who were on medications, which affect blood pressure or
- whose DNA failed to amplify and 8 with errors in Mendelian segregation
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 |
|---|---|---|
| CandesartanAlso: GRK4 polymorphisms and essential hypertrensionTo investigate the response to candesartan among southwestern Han Chinese with essential hypertrension | Drug | candesartan |
Primary outcome
The subjects with GRK4 varirants may exert different response during 4 weeks of treatment with candesartan in patients with essential hypertension
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Derived from this study: PubMed 26871769Cai Y, Yang Y, Chen X, He D, Zhang X, Wen X, Hu J, Fu C, Qiu D, Jose PA, Zeng C, Zhou L. Circulating "LncPPARdelta" From Monocytes as a Novel Biomarker for Coronary Artery Diseases. Medicine (Baltimore). 2016 Feb;95(6):e2360. doi: 10.1097/MD.0000000000002360.
- Derived from this study: PubMed 26201019Yang Y, Cai Y, Wu G, Chen X, Liu Y, Wang X, Yu J, Li C, Chen X, Jose PA, Zhou L, Zeng C. Plasma long non-coding RNA, CoroMarker, a novel biomarker for diagnosis of coronary artery disease. Clin Sci (Lond). 2015 Oct 1;129(8):675-85. doi: 10.1042/CS20150121. Epub 2015 Jun 11.
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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.
Zeng Chunyu, Doctor study director
TMMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Candesartan in people with Essential Hypertension, run by Third Military Medical University 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 1 inclusion and 3 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 18 Nov 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yu changqing, Doctor (02368731850, changqingyu-2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The subjects with GRK4 varirants may exert different response during 4 weeks of treatment with candesartan in patients with essential hypertension (time frame: two years). 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 NCT01629225, 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 18 Nov 2014.