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Capadenoson in Angina Pectoris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00518921
Recruitment Status : Withdrawn
First Posted : August 21, 2007
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
Bayer

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina
Study Start Date : March 2008
Estimated Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518921


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
Mestre, Venezia, Italy, 30174
Genova, Italy, 16132
Pavia, Italy, 27100
Trieste, Italy, 34100
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, 50-420
Wroclaw, Poland, 50-981
Slovakia
Bratislava, Slovakia, 811 04
Bratislava, Slovakia, 813 69
Nitra, Slovakia, 949 01
Nove Zamky, Slovakia, 940 34
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00518921     History of Changes
Other Study ID Numbers: 12484
EudraCT 2007-000425-22
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: January 13, 2011
Last Verified: January 2011

Keywords provided by Bayer:
adenosin agonist
chronic stable angina

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms