Capadenoson in Angina Pectoris

January 12, 2011 updated by: Bayer

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic, 656 91
      • Hodonin, Czech Republic, 695 26
      • Kromeriz, Czech Republic, 767 55
      • Olomouc, Czech Republic, 775 20
      • Ostrava, Czech Republic, 708 52
      • Plzen, Czech Republic, 30599
      • Praha 13, Czech Republic, 158 00
      • Praha 6, Czech Republic, 169 02
  • Hungary
      • Balatonfured, Hungary, 8230
      • Kecskemet, Hungary, 6000
      • Miskolc, Hungary, 3526
      • Pecs, Hungary, 7624
      • Zalaegerszeg, Hungary, 8900
  • Israel
      • Hadera, Israel, 38100
      • Rehovot, Israel, 76100
      • Safed, Israel, 13100
  • Italy
      • Genova, Italy, 16132
      • Pavia, Italy, 27100
      • Trieste, Italy, 34100
    • Venezia
      • Mestre, Venezia, Italy, 30174
  • Poland
      • Bialystok, Poland, 15-276
      • Gdansk, Poland, 80-952
      • Gdynia, Poland, 81-519
      • Katowice, Poland, 40-635
      • Krakow, Poland, 30-501
      • Legnica, Poland, 59-220
      • Lodz, Poland, 91-347
      • Starogard Gdanski, Poland, 83-200
      • Szczecin, Poland, 70-111
      • Warszawa, Poland, 03-401
      • Wroclaw, Poland, 50-981
      • Wroclaw, Poland, 50-420
  • Slovakia
      • Bratislava, Slovakia, 813 69
      • Bratislava, Slovakia, 811 04
      • Nitra, Slovakia, 949 01
      • Nove Zamky, Slovakia, 940 34

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Capadenoson (BAY 68-4986)
1mg Capadenoson, double dummy
Drug: Capadenoson (BAY 68-4986)
2mg Capadenoson, double dummy
Drug: Capadenoson (BAY 68-4986)
4mg Capadenoson, double dummy
Experimental: Arm 2
Drug: Capadenoson (BAY 68-4986)
1mg Capadenoson, double dummy
Drug: Capadenoson (BAY 68-4986)
2mg Capadenoson, double dummy
Drug: Capadenoson (BAY 68-4986)
4mg Capadenoson, double dummy
Experimental: Arm 3
Drug: Capadenoson (BAY 68-4986)
1mg Capadenoson, double dummy
Drug: Capadenoson (BAY 68-4986)
2mg Capadenoson, double dummy
Drug: Capadenoson (BAY 68-4986)
4mg Capadenoson, double dummy
Placebo Comparator: Arm 4
Drug: Placebo
Placebo, double dummy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total exercise time
Time Frame: 28 days for ETT and 42 days for safety
28 days for ETT and 42 days for safety

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to angina onset
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Study Completion (Anticipated)

November 1, 2008

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

January 13, 2011

Last Update Submitted That Met QC Criteria

January 12, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12484
  • EudraCT 2007-000425-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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