Zainidip in Renal Artery Stenosis

• Sponsor: Lee's Pharmaceutical Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02594410
• Collaborator: (none)
• Enrollment: 149
• Location: 1
• Arm: 1
• Duration (Months): 32
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Device: stent; Drug: Aspirine; Drug: Clopidogrel; Drug: Lercanidipine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Renal Artery Stent Combined With Standardized Medical Therapy in Patients With Atherosclerotic Renal Artery Stenosis
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis	Device: stent; patients receiving renal artery stenting for renal artery atherosclerosis; Drug: Aspirine; 100mg Qd; Drug: Clopidogrel; 75mg Qd; Drug: Lercanidipine; 10-20mg Qd

Outcome Measures

Primary Outcome Measures

1. Glomerular filtration rate [12 months]

2. Blood pressure [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing		China

Sponsors and Collaborators

• Lee's Pharmaceutical Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lee's Pharmaceutical Limited
• ClinicalTrials.gov Identifier: NCT02594410
• Other Study ID Numbers: Zhaoke-1503-zanidip
• First Posted: Nov 3, 2015
• Last Update Posted: Nov 3, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Renal Artery Obstruction; Lercanidipine; Clopidogrel

Study Results

No Results Posted as of Nov 3, 2015