Capadenoson in Angina Pectoris

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00518921
First received: August 20, 2007
Last updated: January 12, 2011
Last verified: January 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to angina onset [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: August 20, 2007
Last Updated: January 12, 2011
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Bayer:
adenosin agonist
chronic stable angina

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

ClinicalTrials.gov processed this record on September 22, 2014