Back to resultsCapadenoson in Angina Pectoris
Primary Purpose
Chronic Stable Angina
Status
Withdrawn
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Capadenoson (BAY 68-4986)
Capadenoson (BAY 68-4986)
Capadenoson (BAY 68-4986)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Stable Angina focused on measuring adenosin agonist, chronic stable angina
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm Description
Outcomes
Primary Outcome Measures
Total exercise time
Secondary Outcome Measures
Time to angina onset
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00518921
Brief Title
Capadenoson in Angina Pectoris
Official Title
Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Withdrawn
Study Start Date
March 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2008 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina
Keywords
adenosin agonist, chronic stable angina
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Experimental
Arm Title
Arm 3
Arm Type
Experimental
Arm Title
Arm 4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Capadenoson (BAY 68-4986)
Intervention Description
1mg Capadenoson, double dummy
Intervention Type
Drug
Intervention Name(s)
Capadenoson (BAY 68-4986)
Intervention Description
2mg Capadenoson, double dummy
Intervention Type
Drug
Intervention Name(s)
Capadenoson (BAY 68-4986)
Intervention Description
4mg Capadenoson, double dummy
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, double dummy
Primary Outcome Measure Information:
Title
Total exercise time
Time Frame
28 days for ETT and 42 days for safety
Secondary Outcome Measure Information:
Title
Time to angina onset
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Brno
ZIP/Postal Code
656 91
Country
Czech Republic
City
Hodonin
ZIP/Postal Code
695 26
Country
Czech Republic
City
Kromeriz
ZIP/Postal Code
767 55
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czech Republic
City
Plzen
ZIP/Postal Code
30599
Country
Czech Republic
City
Praha 13
ZIP/Postal Code
158 00
Country
Czech Republic
City
Praha 6
ZIP/Postal Code
169 02
Country
Czech Republic
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
City
Hadera
ZIP/Postal Code
38100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Safed
ZIP/Postal Code
13100
Country
Israel
City
Mestre
State/Province
Venezia
ZIP/Postal Code
30174
Country
Italy
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Trieste
ZIP/Postal Code
34100
Country
Italy
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Krakow
ZIP/Postal Code
30-501
Country
Poland
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
City
Starogard Gdanski
ZIP/Postal Code
83-200
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Warszawa
ZIP/Postal Code
03-401
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-420
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
City
Bratislava
ZIP/Postal Code
811 04
Country
Slovakia
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
12. IPD Sharing Statement
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Capadenoson in Angina Pectoris
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