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Effect of Molsidomine on the Endothelial (Internal Layer of Blood Vessels) Dysfunction in Patients With Angina Pectoris

NCT01363661 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2014-10-06

Study results available
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Summary

Molsidomine used as an add-on treatment on standard care therapy should be superior to placebo used also as an add-on treatment on standard care therapy on improving the endothelial function (endothelium score measured by reactive hyperemia - peripheral arterial tonometry \[RH-PAT\]) after 12 months of treatment in patients with stable angina patients and undergoing elective percutaneous coronary intervention.

The study will be double-blind, parallel-group, randomised, multicentre, sequential, placebo-controlled study.

The device used to determine RH-PAT will be EndoPAT. Duration of the treatment = one year.

Conditions

Interventions

DRUG

Coruno

Molsidomine 16 mg tablet, per os, once a day

DRUG

Placebo

Placebo (16 mg tablet, per os; once-daily)

Sponsors & Collaborators

  • Therabel Pharma SA/NV

    lead INDUSTRY

Principal Investigators

  • Emanuele Barbato, MD · Cardiology Center, Onze Lieve Vrouw Ziekenhuis Aalst

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363661 on ClinicalTrials.gov