This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452.
The primary objective of this study is to assess the effect of intravenous (i.v.) CK-1827452 on symptom-limited exercise tolerance in patients with ischemic cardiomyopathy and angina. The secondary objectives are to assess the tolerability of CK-1827452 administered three times daily (tid) to steady state in an immediate-release (IR), blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina and to assess CK-1827452 plasma concentrations at trough and 1 hour after dosing with CK-1827452 administered tid to steady state in an IR, blend-in-capsule oral formulation to outpatients with ischemic cardiomyopathy and angina.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
94
I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr
12.5mg oral immediate release capsule
I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr
Tbilisi State Medical University Clinic #1
Tbilisi, Georgia
Cardio-Reanimation Centre
Tbilisi, Georgia
Cardiology Clinic
Tbilisi, Georgia
Participants Stopping Exercise Treadmill Test 3 (ETT-3) for Angina at Stage Earlier Than Baseline Exercise Treadmill Test (ETT-B)
The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.
Time frame: 1 day
Participants Stopping ETT-3 for Any Reason at Stage Earlier Than ETT-B
The Modified Naughton Exercise Treadmill Test was employed in this study. Exercise Treadmill Test 3 (ETT-3) was performed during the last 2 hours of the 20-hour infusion of study drug or placebo. Baseline Exercise Treadmill Test (ETT-B) was performed prior to dosing.
Time frame: 1 day
Increase in Exercise Duration During ETT-3 vs. ETT-B
Time frame: 1 day
Participants Stopping ETT-3 for Angina at Any Stage
This Outcome Measure includes all participants who stopped ETT-3 for angina at any stage, not only those who stopped at a stage earlier than ETT-B. Note: All 9 subjects who stopped ETT-3 for angina also stopped ETT-B for angina.
Time frame: 1 day
Participants With 1 mm ST Segment Depression During ETT-3
ST Segment Depression measured by Electrocardiography while performing ETT-3.
Time frame: 1 day
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25mg oral immediate release capsule
Matching placebo iv infusion
Matching placebo oral immediate release capsule
National Center of Therapy
Tbilisi, Georgia
Multiprofile Clinical Hospital of Tbilisi #2
Tbilisi, Georgia
Diagnostic Services Clinic
Tbilisi, Georgia
Altay Territory Cardiology Dispensary
Barnaul, Russia
City Hospital #1
Barnaul, Russia
City Clinical Hospital #59
Moscow, Russia
City Clinical Hospital #64
Moscow, Russia
...and 4 more locations