Chronic Stable Angina
Conditions
Keywords
adenosin agonist, chronic stable angina
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.
Interventions
DRUGCapadenoson (BAY 68-4986)
1mg Capadenoson, double dummy
DRUGPlacebo
Placebo, double dummy
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total exercise time | 28 days for ETT and 42 days for safety |
Secondary
| Measure | Time frame |
|---|---|
| Time to angina onset | 28 days |
Countries
Czechia, Hungary, Israel, Italy, Poland, Slovakia
Outcome results
None listed