HypertensionPhase 4NCT00360763
Study of Optimal Treatment Plan in Hypertensives With Anti-AT1-Receptor Autoantibody
A Phase 4 study testing candesartan cilexetil in people with Hypertension, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in patients with hypertension. ATR-AA which can blocked by ARB may play a role in the pathogenesis of hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- candesartan cilexetil
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- Start not givento Dec 2006
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension (2 grade)
Who cannot join
- Secondary hypertension
- Known sensitivity or intolerance to an angiotensin II receptor antagonist or ACE inhibitor
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Cardiology, Wuhan Union Hospital
Wuhan, Hubei, 430022
Yu-Hua Liao, Doctor, 00862785726376, yumiaowei@vip.sina.com
About this study
The autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in patients with hypertension. ATR-AA which can blocked by ARB may play a role in the pathogenesis of hypertension. The present study is to explore whether AT1 receptor blocker has superior anti-hypertensive effect in patients with positive ATR-AA hypertension. Patients with 2 grade hypertension were recruited and ATR-AA was assayed by ELISA. A study was carried out and the efficacy of anti-hypertension was compared between candesartan cilexetil and ACE inhibitor imidapril.
- Conditions
- Hypertension
- Being tested
- candesartan cilexetil
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
candesartan cilexetilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2006 (estimated)
- Study completionDec 2006
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 HypertensionStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Investigators
- Yu-Hua Liao, Study director, Union Hospital, Tongji Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360763
- Sponsor's protocol ID
- UH-01
- Status last verified
- Aug 2006
- First submitted
- 4 Aug 2006
- Last updated
- 7 Aug 2006
- Results posted
- No
Publications
Liao YH, Wei YM, Wang M, Wang ZH, Yuan HT, Cheng LX. Autoantibodies against AT1-receptor and alpha1-adrenergic receptor in patients with hypertension. Hypertens Res. 2002 Jul;25(4):641-6. doi: 10.1291/hypres.25.641.
PubMed 12358154Wei F, Jia XJ, Yu SQ, Gu Y, Wang L, Guo XM, Wang M, Zhu F, Cheng X, Wei YM, Zhou ZH, Fu M, Liao YH; SOT-AT1 Study Group. Candesartan versus imidapril in hypertension: a randomised study to assess effects of anti-AT1 receptor autoantibodies. Heart. 2011 Mar;97(6):479-84. doi: 10.1136/hrt.2009.192104. Epub 2011 Feb 4.
PubMed 21296780
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Optimal Treatment Plan in Hypertensives With Anti-AT1-Receptor Autoantibody
- ClinicalTrials.gov ID
- NCT00360763
- Acronym / sponsor ID
- UH-01
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study completion
- Dec 2006
- First posted
- 7 Aug 2006 (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 autoantibodies against AT1 receptor (ATR-AA), behaving like an agonist were detected in patients with hypertension. ATR-AA which can blocked by ARB may play a role in the pathogenesis of hypertension. The present study is to explore whether AT1 receptor blocker has superior anti-hypertensive effect in patients with positive ATR-AA hypertension. Patients with 2 grade hypertension were recruited and ATR-AA was assayed by ELISA. A study was carried out and the efficacy of anti-hypertension was compared between candesartan cilexetil and ACE inhibitor imidapril.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hypertension (2 grade)
Key exclusion criteria (3 listed)
- Secondary hypertension
- Known sensitivity or intolerance to an angiotensin II receptor antagonist or ACE inhibitor
- Pregnancy
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 |
|---|---|---|
| candesartan cilexetil | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2006.
- Background: PubMed 12358154Liao YH, Wei YM, Wang M, Wang ZH, Yuan HT, Cheng LX. Autoantibodies against AT1-receptor and alpha1-adrenergic receptor in patients with hypertension. Hypertens Res. 2002 Jul;25(4):641-6. doi: 10.1291/hypres.25.641.
- Derived from this study: PubMed 21296780Wei F, Jia XJ, Yu SQ, Gu Y, Wang L, Guo XM, Wang M, Zhu F, Cheng X, Wei YM, Zhou ZH, Fu M, Liao YH; SOT-AT1 Study Group. Candesartan versus imidapril in hypertension: a randomised study to assess effects of anti-AT1 receptor autoantibodies. Heart. 2011 Mar;97(6):479-84. doi: 10.1136/hrt.2009.192104. Epub 2011 Feb 4.
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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.
Yu-Hua Liao study director
Union Hospital, Tongji Medical College
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 cilexetil in people with Hypertension, run by Huazhong University of Science and Technology 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 7 Aug 2006. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00360763, 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 7 Aug 2006.