Zainidip in Renal Artery Stenosis

NCT ID: NCT02594410

Last Updated: 2015-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-05-31

Brief Summary

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To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis

Group Type EXPERIMENTAL

stent

Intervention Type DEVICE

patients receiving renal artery stenting for renal artery atherosclerosis

Aspirine

Intervention Type DRUG

100mg Qd

Clopidogrel

Intervention Type DRUG

75mg Qd

Lercanidipine

Intervention Type DRUG

10-20mg Qd

Interventions

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stent

patients receiving renal artery stenting for renal artery atherosclerosis

Intervention Type DEVICE

Aspirine

100mg Qd

Intervention Type DRUG

Clopidogrel

75mg Qd

Intervention Type DRUG

Lercanidipine

10-20mg Qd

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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Zhaoke-1503-zanidip

Identifier Type: -

Identifier Source: org_study_id

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