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Capadenoson in Angina Pectoris

This study has been withdrawn prior to enrollment.
Information provided by:
Bayer Identifier:
First received: August 20, 2007
Last updated: January 12, 2011
Last verified: January 2011
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.

Condition Intervention Phase
Chronic Stable Angina
Drug: Capadenoson (BAY 68-4986)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Total exercise time [ Time Frame: 28 days for ETT and 42 days for safety ]

Secondary Outcome Measures:
  • Time to angina onset [ Time Frame: 28 days ]

Enrollment: 0
Study Start Date: March 2008
Estimated Study Completion Date: November 2008
Arms Assigned Interventions
Experimental: Arm 1 Drug: Capadenoson (BAY 68-4986)
1mg Capadenoson, double dummy
Experimental: Arm 2 Drug: Capadenoson (BAY 68-4986)
2mg Capadenoson, double dummy
Experimental: Arm 3 Drug: Capadenoson (BAY 68-4986)
4mg Capadenoson, double dummy
Placebo Comparator: Arm 4 Drug: Placebo
Placebo, double dummy


Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00518921

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
Balatonfured, Hungary, 8230
Kecskemet, Hungary, 6000
Miskolc, Hungary, 3526
Pecs, Hungary, 7624
Zalaegerszeg, Hungary, 8900
Hadera, Israel, 38100
Rehovot, Israel, 76100
Safed, Israel, 13100
Mestre, Venezia, Italy, 30174
Genova, Italy, 16132
Pavia, Italy, 27100
Trieste, Italy, 34100
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, 50-420
Wroclaw, Poland, 50-981
Bratislava, Slovakia, 811 04
Bratislava, Slovakia, 813 69
Nitra, Slovakia, 949 01
Nove Zamky, Slovakia, 940 34
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG Identifier: NCT00518921     History of Changes
Other Study ID Numbers: 12484
EudraCT 2007-000425-22
Study First Received: August 20, 2007
Last Updated: January 12, 2011

Keywords provided by Bayer:
adenosin agonist
chronic stable angina

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms processed this record on April 24, 2017