Last updated: 11/04/2018 06:05:40
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients with Chronic Heart Failure
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to evaluate the safety and tolerability of SK&F-105517-D in patients with chronic heart failure- An open-label study to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of SK&F-105517-D in patients with chronic heart failure (Phase I/II study)
Trial description: The primary objective of this study is to evaluate the safety and tolerability of SK&F-105517-D in japanese patients with chronic heart failure.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Number of Participants with Adverse Events by Severity from Week 0 through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)
Timeframe: Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D
Mean Change from Baseline in Albumin and Total Protein at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Amylase at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Hematocrit at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Platelet Count and White Blood Cell Count at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Red Blood Cell Count at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Mean Corpuscular Hemoglobin at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Mean Corpuscular Volume at Week 8
Timeframe: Baseline and Week 8
Number of Participants with the Indicated Urinalysis Dipstick Results at Baseline and Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Heart Rate at Week 8
Timeframe: Baseline and Week 8
Mean Change from Baseline in Weight at Week 8
Timeframe: Baseline and Week 8
Number of Participants with the Indicated Electrocardiogram Findings at Baseline and Week 8
Timeframe: Baseline and Week 8
Cardiothoracic Ratio at Baseline and Week 8
Timeframe: Baseline and Week 8
Secondary outcomes:
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Timeframe: Week 8
Area Under the Plasma Concentration versus Time Curve from Time Zero to 24 hours (AUC0-24) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Timeframe: Week 8
Time of Maximal Plasma Concentration (tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Timeframe: Week 8
Adjusted Mean Change from Baseline in Systolic Blood Pressure at Week 8
Timeframe: Baseline and Week 8
Adjusted Mean Change from Baseline in Diastolic Blood Pressure at Week 8
Timeframe: Baseline and Week 8
Adjusted Mean Change from Baseline in Mean Heart Rate at Week 8
Timeframe: Baseline and Week 8
Number of Participants with the Indicated Change from Baseline New York Heart Association (NYHA) Functional Class at Week 8
Timeframe: Baseline and Week 8
Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8
Timeframe: Baseline and Week 8
Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8
Timeframe: Baseline and Week 8
Interventions:
Drug: SK&F-105517-D 10 mg capsule
Drug: Carvedilol-immediate release (IR) 2.5 mg tablet
Drug: SK&F-105517-D 20 mg capsule
Drug: SK&F-105517-D 40 mg capsule
Drug: Carvedilol-IR 10 mg tablet
Enrollment:
41
Observational study model:
Not applicable
Primary completion date:
2009-21-08
Time perspective:
Not applicable
Clinical publications:
Kitakaze M, Sarai N, Ando H, Sakamoto T, Nakajima H. Safety and Tolerability of Once-daily Controlled-release Carvedilol 10- 80 mg in Japanese Patients with Chronic Heart Failure. [Circ J]. 2012;Advance Publication(.):..
Medical condition
Heart failure, Congestive
Product
carvedilol
Collaborators
Not applicable
Study date(s)
August 2008 to August 2009
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
20 - 80 years
Accepts healthy volunteers
No
- Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy
- Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their dosage/administration is not changed within 2 weeks
- Patients contraindicated for ß-blockers
- Patients with occurrence of acute myocardial infarction within 2 weeks
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with symptomatically stable chronic heart failure (CHF) based on ischemic heart disease or dilated cardiomyopathy -Patients who are maintained on basic heart failure therapy with angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) and their dosage/administration is not changed within 2 weeks -Patients diagnosed with New York Heart Association (NYHA) class I to III -Patients with a left ventricular ejection fraction (LVEF) between 25% and 45%
Exclusion criteria:
- Patients contraindicated for ß-blockers -Patients with occurrence of acute myocardial infarction within 2 weeks -Patients with unstable angina, coronary spastic angina, or angina at rest -Patients who have collected blood >400 mL within 4 months prior to screening or >200 mL within 1 months
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-21-08
Actual study completion date
2009-21-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 110734 can be found on the GSK Clinical Study Register.
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