Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Cytokinetics |
---|---|
Information provided by: | Cytokinetics |
ClinicalTrials.gov Identifier: | NCT00682565 |
This study investigates whether symptom-limited exercise capacity in ischemic cardiomyopathy patients with angina is deleteriously affected by treatment with CK-1827452.
Condition | Intervention | Phase |
---|---|---|
Heart Failure Myocardial Ischemia Angina Pectoris |
Drug: CK-1827452 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study |
Official Title: | Tolerability and CK-1827452 Plasma Concentrations During Intravenous and Immediate-Release Oral CK-1827452 In Patients With Ischemic Cardiomyopathy and Angina |
Estimated Enrollment: | 90 |
Study Start Date: | April 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1: Experimental
CK-1827452 or placebo 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
|
Drug: CK-1827452
I.V. infusion for 2 hours at 24mg/hr followed by 18 hours at 6mg/hr
Drug: CK-1827452
12.5mg oral immediate release capsule
Drug: Placebo
I.V. infusion for 20 hours
Drug: Placebo
Matching placebo oral immediate release capsule
|
Cohort 2: Experimental
CK-1827452 or placebo 20 hour infusion followed by 6 days three times a day oral dose and a final single oral dose
|
Drug: CK-1827452
I.V. infusion for 2 hours at 48mg/hr followed by 18 hours at 11mg/hr
Drug: CK-1827452
25mg oral immediate release capsule
Drug: Placebo
I.V. infusion for 20 hours
Drug: Placebo
Matching placebo oral immediate release capsule
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patient has ischemic heart disease documented by any one or more of the following:
Exclusion Criteria:
Georgia | |
Cardio-Reanimation Centre | |
Tbilisi, Georgia, 0141 | |
National Center of Therapy | |
Tbilisi, Georgia, 0159 | |
Diagnostic Services Clinic | |
Tbilisi, Georgia, 0179 | |
Cardiology Clinic | |
Tbilisi, Georgia, 0144 | |
Tbilisi State Medical University Clinic #1 | |
Tbilisi, Georgia, 0102 | |
Multiprofile Clinical Hospital of Tbilisi #2 | |
Tbilisi, Georgia, 0164 | |
Russian Federation | |
Altay Territory Cardiology Dispensary | |
Barnaul, Russian Federation | |
Research Centre for Cardiology n.a. Almazov under Roszdrav | |
St. Petersburg, Russian Federation | |
Federal Center of Heart, Blood and Endocrinology n.a. Almazov | |
St. Petersburg, Russian Federation | |
City Clinical Hospital #59 | |
Moscow, Russian Federation | |
Volgograd Regional Cardiology Center | |
Volgograd, Russian Federation | |
Moscow Municipal Clinical Hospital #4 | |
Moscow, Russian Federation | |
City Clinical Hospital #64 | |
Moscow, Russian Federation | |
City Hospital #1 | |
Barnaul, Russian Federation |
Responsible Party: | Cytokinetics, Inc. ( Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer ) |
Study ID Numbers: | CY 1221 |
Study First Received: | May 20, 2008 |
Last Updated: | November 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00682565 |
Health Authority: | Georgia: Ministry of Health |
Signs and Symptoms Heart Failure Heart Diseases Myocardial Ischemia Vascular Diseases |
Angina Pectoris Pain Ischemia Cardiomyopathies Chest Pain |
Pathologic Processes Cardiovascular Diseases |