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NCT00518921 Clinical Trial

Capadenoson in Angina Pectoris

Chronic Stable Angina Clinical Trial

Official title:
Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00518921
Other study ID # 12484
Secondary ID EudraCT 2007-000
Status Withdrawn
Phase Phase 2
First received August 20, 2007
Last updated January 12, 2011
Start date March 2008
Est. completion date November 2008

Study information
Verified date January 2011
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Study type Interventional

Clinical Trial Summary

This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date November 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 75 Years
Eligibility Inclusion Criteria:

- The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease.

- Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized)

- Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks

Exclusion Criteria:

- Inability to withdraw current anti-anginal therapy

- Inability to withdraw any concomitant therapy that would interfere with interpretation of study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Capadenoson (BAY 68-4986)
1mg Capadenoson, double dummy
• Capadenoson (BAY 68-4986)
2mg Capadenoson, double dummy
• Capadenoson (BAY 68-4986)
4mg Capadenoson, double dummy
• Placebo
Placebo, double dummy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Israel,  Italy,  Poland,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total exercise time 28 days for ETT and 42 days for safety No
Secondary Time to angina onset 28 days No
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