HypertensionPhase 4NCT02594410
Zainidip in Renal Artery Stenosis
A Phase 4 study testing stent, Aspirine and Clopidogrel in people with Hypertension, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- stent, Aspirine and Clopidogrel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- Sep 2011to May 2014
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 - 75
- Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
- Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
- length of ipsilateral kidney is greater than 7.0cm.
Who cannot join
- Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];
- unstable condition and unable to tolerate interventional therapy;
- anatomy of renal artery pathology not suitable for interventional therapy;
- allergic to dihydropyridines;
- III degree atrioventricular block
- contrast allergy ;
- any known malignant tumor;
- non-compliant, history of alcoholism or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis
To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.
- Conditions
- Hypertension
- Being tested
- stent, Aspirine, Clopidogrel, Lercanidipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stentDevice
patients receiving renal artery stenting for renal artery atherosclerosis
AspirineDrug
100mg Qd
ClopidogrelDrug
75mg Qd
LercanidipineDrug
10-20mg Qd
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis Receives: Device: stent; Drug: Aspirine; Drug: Clopidogrel; Drug: Lercanidipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
Measured: 12 months
Blood pressure
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594410
- Sponsor's protocol ID
- Zhaoke-1503-zanidip
- Status last verified
- Oct 2015
- First submitted
- 29 Oct 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis
- ClinicalTrials.gov ID
- NCT02594410
- Acronym / sponsor ID
- Zhaoke-1503-zanidip
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 3 Nov 2015 (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.
To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: stent, Drug: Aspirine, Drug: Clopidogrel, Drug: Lercanidipinepatients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 40 - 75
- Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
- Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
- length of ipsilateral kidney is greater than 7.0cm.
Key exclusion criteria (8 listed)
- Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];
- unstable condition and unable to tolerate interventional therapy;
- anatomy of renal artery pathology not suitable for interventional therapy;
- allergic to dihydropyridines;
- III degree atrioventricular block
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 |
|---|---|---|
| stentpatients receiving renal artery stenting for renal artery atherosclerosis | Device | Treatment |
| Aspirine100mg Qd | Drug | Treatment |
| Clopidogrel75mg Qd | Drug | Treatment |
| Lercanidipine10-20mg Qd | Drug | Treatment |
Primary outcome
Glomerular filtration rate
Time frame: 12 months
Blood pressure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 stent, Aspirine and Clopidogrel in people with Hypertension, run by Lee's Pharmaceutical Limited 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 3 Nov 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (time frame: 12 months). 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?
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 3 Nov 2015.