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Sponsored by: |
Cytokinetics |
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Information provided by: | Cytokinetics |
ClinicalTrials.gov Identifier: | NCT00624442 |
This study will assess the safety, tolerability, and pharmacodynamics of CK-1827452 infusion in patients with stable heart failure.
Condition | Intervention | Phase |
---|---|---|
Heart Failure |
Drug: CK-1827452 Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multi Center, Double-Blind, Randomized, Placebo Controlled, Dose-Escalation, Pharmacokinetic and Pharmacodynamic Study of CK-1827452 in Patients With Stable Heart Failure |
Estimated Enrollment: | 40 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohort 1: Experimental
2 hour infusion of one of three dose levels of CK-1827452 or placebo.
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Drug: CK-1827452
I.V. infusion for 1 hour at 0.125mg/kg/hr followed by 1 hour at 0.0625mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 0.25mg/kg/hr followed by 1 hour at 0.125mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 0.5mg/kg/hr followed by 1 hour at 0.25mg/kg/hr
Drug: Placebo
I.V. infusion for 2 hours
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Cohort 2: Experimental
2 hour infusion of one of three dose levels of CK-1827452 or placebo.
|
Drug: CK-1827452
I.V. infusion for 1 hour at 0.5mg/kg/hr followed by 1 hour at 0.25mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 0.75mg/kg/hr followed by 1 hour at 0.375mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 1.0mg/kg/hr followed by 1 hour at 0.5mg/kg/hr
Drug: Placebo
I.V. infusion for 2 hours
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Cohort 3: Experimental
24 hour infusion of one of three dose levels of CK-1827452 or placebo.
|
Drug: CK-1827452
I.V. infusion for 1 hour at 0.25mg/kg/hr followed by 1 hour at 0.125mg/kg/hr followed by 22 hours at 0.025mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 0.5mg/kg/hr followed by 1 hour at 0.25mg/kg/hr followed by 22 hours at 0.05mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 1.0mg/kg/hr followed by 1 hour at 0.5mg/kg/hr followed by 22 hours at 0.1mg/kg/hr
Drug: Placebo
I.V. infusion for 24 hours
|
Cohort 4: Experimental
24 hour infusion of one of three dose levels of CK-1827452 or placebo.
|
Drug: CK-1827452
I.V. infusion for 1 hour at 0.25mg/kg/hr followed by 1 hour at 0.125mg/kg/hr followed by 22 hours at 0.025mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 0.5mg/kg/hr followed by 1 hour at 0.25mg/kg/hr followed by 22 hours at 0.05mg/kg/hr
Drug: CK-1827452
I.V. infusion for 1 hour at 1.0mg/kg/hr followed by 1 hour at 0.5mg/kg/hr followed by 22 hours at 0.1mg/kg/hr
Drug: Placebo
I.V. infusion for 24 hours
|
Cohort 5: Experimental
72 hour infusion with one dose level of CK-1827452 or placebo.
|
Drug: CK-1827452
I.V. infusion for 1 hour at 1.0mg/kg/hr followed 1 hour at 0.5mg/kg/hr followed by 70 hours at 0.1mg/kg/hr
Drug: Placebo
I.V. infusion for 72 hours
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patient is considered to be in suitable health in the opinion of the investigator, as determined by:
Exclusion Criteria
Contact: Cyril Clarke, MB BS, MFPM | clarkec@iconuk.com |
United States, California | |
University of California, San Diego Medical Center | Recruiting |
San Diego, California, United States, 92103 | |
United States, Delaware | |
Christiana Care Health Services, Inc. | Recruiting |
Newark, Delaware, United States, 19713 | |
Georgia | |
Diagnostic Services Clinic | Recruiting |
Tbilisi, Georgia | |
Russian Federation, Russia | |
St. Petersburg State Medical University | Recruiting |
St. Petersburg, Russia, Russian Federation, 197089 | |
Almazov Federal Heart, Blood and Endocrinology Center | Recruiting |
St. Petersburg, Russia, Russian Federation, 194156 | |
Russian Cardiological Research and Production Complex | Recruiting |
Moscow, Russia, Russian Federation, 121552 | |
United Kingdom, England | |
Manchester Heart Centre, Manchester Royal Infirmary | Recruiting |
Manchester, England, United Kingdom, M13 9WL | |
Wythenshawe Hospital | Recruiting |
Manchester, England, United Kingdom, M23 9LT | |
Castle Hill Hospital, University of Hull | Recruiting |
Hull, England, United Kingdom, HU16 5JQ | |
King's College Hospital | Recruiting |
London, England, United Kingdom, SE5 9RS | |
Northwick Park Hospital | Recruiting |
Middlesex, England, United Kingdom, HA1 3UJ | |
ICON Development Solutions | Active, not recruiting |
Manchester, England, United Kingdom, M15 6SH | |
St. Mary's Hospital & Imperial College | Recruiting |
London, England, United Kingdom, W2 1LA | |
St. George's Hospital | Recruiting |
London, England, United Kingdom, SW17 ORE | |
United Kingdom, Scotland | |
BHF Cardiovascular Centre | Recruiting |
Glasgow, Scotland, United Kingdom, G12 8TA | |
Ninewells Hospital and Medical School | Recruiting |
Dundee, Scotland, United Kingdom, DD1 9SY |
Responsible Party: | Cytokinetics, Inc. ( Andrew Wolff, M.D., F.A.C.C., Chief Medical Officer ) |
Study ID Numbers: | CY 1121 |
Study First Received: | December 21, 2007 |
Last Updated: | January 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00624442 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; Russia: Ministry of Health and Social Development of the Russian Federation; United States: Food and Drug Administration |
Heart Failure Heart Diseases |
Cardiovascular Diseases |