Zainidip in Renal Artery Stenosis

Hypertension Clinical Trial

Official title:

The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594410
• Other study ID #: Zhaoke-1503-zanidip
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2015
• Last updated: October 30, 2015
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: October 2015
• Source: Lee's Pharmaceutical Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Renal Artery Obstruction

Intervention

Device:
• stent
patients receiving renal artery stenting for renal artery atherosclerosis

Drug:
• Aspirine
100mg Qd
• Clopidogrel
75mg Qd
• Lercanidipine
10-20mg Qd

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glomerular filtration rate		12 months	No
Primary	Blood pressure		12 months	No