Back to resultsA Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
SK&F-105517-D 10 mg capsule
Carvedilol-immediate release (IR) 2.5 mg tablet
SK&F-105517-D 20 mg capsule
SK&F-105517-D 40 mg capsule
Carvedilol-IR 10 mg tablet
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring carvedilol phosphate, ß-blocker, SK&F-105517-D, Chronic heart failure(CHF)
Eligibility 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
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
SK&F-105517-D group
Carvedilol-IR group
Arm Description
SK&F-105517-D 10-80 mg/day
Carvedilol-IR 5-20 mg/day
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)
Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.
Mean Change From Baseline in Albumin and Total Protein at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Amylase at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.
Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Hematocrit at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Red Blood Cell Count at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Mean Corpuscular Volume at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8
Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Heart Rate at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean Change From Baseline in Weight at Week 8
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8
There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.
Cardiothoracic Ratio at Baseline and Week 8
Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.
Secondary Outcome Measures
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
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
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) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8
The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.
Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8
Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.
Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8
Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00742508
Brief Title
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
August 28, 2008 (Actual)
Primary Completion Date
August 21, 2009 (Actual)
Study Completion Date
August 21, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
carvedilol phosphate, ß-blocker, SK&F-105517-D, Chronic heart failure(CHF)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SK&F-105517-D group
Arm Type
Experimental
Arm Description
SK&F-105517-D 10-80 mg/day
Arm Title
Carvedilol-IR group
Arm Type
Other
Arm Description
Carvedilol-IR 5-20 mg/day
Intervention Type
Drug
Intervention Name(s)
SK&F-105517-D 10 mg capsule
Other Intervention Name(s)
carvedilol phosphate
Intervention Description
1 capsule once a day
Intervention Type
Drug
Intervention Name(s)
Carvedilol-immediate release (IR) 2.5 mg tablet
Intervention Description
1 or 2 tablet(s) twice a day
Intervention Type
Drug
Intervention Name(s)
SK&F-105517-D 20 mg capsule
Other Intervention Name(s)
carvedilol phosphate
Intervention Description
1 capsule once a day
Intervention Type
Drug
Intervention Name(s)
SK&F-105517-D 40 mg capsule
Other Intervention Name(s)
carvedilol phosphate
Intervention Description
1 or 2 capsule(s) once a day
Intervention Type
Drug
Intervention Name(s)
Carvedilol-IR 10 mg tablet
Intervention Description
1 tablet twice a day
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)
Description
Drug-related adverse events (AEs) were defined as AEs that were judged to have a relationship with the investigational product by the investigator (or subinvestigator) with the use of clinical judgment and the Clinical Investigator Brochure to determine the relationship. Refer to adverse event information for type and frequency of adverse events.
Time Frame
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
Title
Mean Change From Baseline in Albumin and Total Protein at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, Creatine Kinase, and Gamma Glutamyl Transferase at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Amylase at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Total Bilirubin, Creatinine, and Uric Acid at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Creatine Kinase BB Percentage, Creatine Kinase MB Percentage, and Creatine Kinase MM Percentage at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value. (BB, brain-derived; MB=cardiac muscle-derived; MM=skeletal muscle-derived.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Each Type of White Blood Cell (WBC) (Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils) at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Hemoglobin and Mean Corpuscular Hemoglobin Concentration at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Hematocrit at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Platelet Count and White Blood Cell Count at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Red Blood Cell Count at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Mean Corpuscular Hemoglobin at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Mean Corpuscular Volume at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Number of Participants With the Indicated Urinalysis Dipstick Results at Baseline and Week 8
Description
Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Heart Rate at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Mean Change From Baseline in Weight at Week 8
Description
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Time Frame
Baseline and Week 8
Title
Number of Participants With the Indicated Electrocardiogram Findings at Baseline and Week 8
Description
There are 3 categories for electrocardiogram (ECG) findings: normal; abnormal, not clinically significant; and abnormal, clinically significant. Each of the findings was classified by the investigator according to whether it was normal. Abnormal ECGs were further classified according to whether they were felt to be clinically significant in the medical and scientific judgment of the investigator.
Time Frame
Baseline and Week 8
Title
Cardiothoracic Ratio at Baseline and Week 8
Description
Cardiothoracic ratio is a marker of the degree of heart enlargement and was measured by chest X-ray. It is shown as the ratio of the transverse diameter of the heart to the transverse diameter of the thorax, and is measured as a percentage.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Description
Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 active Metabolite (SB-203231) were measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Time Frame
Week 8
Title
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
Description
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) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. The analysis was performed on log-transformed data. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Time Frame
Week 8
Title
Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8
Description
Time of maximal plasma concentration (tmax) of S-carvedilol, R-carvedilol, and M4 active metabolite (SB-203231) was measured. Participants in each treatment group were divided into 3 groups by pharmacokinetic sampling timing: Groups A, B, and C in the SK&F-105517-D group and Groups D, E, and F in the CRV-IR group. Carvedilol is a racemic mixture. Non-selective β-blocking activity is shown by S-carvedilol, while α1-blocking activity is shown by both S-carvedilol and R-carvedilol.
Time Frame
Week 8
Title
Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8
Description
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Time Frame
Baseline and Week 8
Title
Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8
Description
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Time Frame
Baseline and Week 8
Title
Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8
Description
Pharmacodynamic (PD) assessment points were 24 hours (h) (from time of first reading to time of last reading), morning (6 am-12 pm), afternoon (12-6 pm), night (6 pm-6 am on following day), waking (8 am-9 pm), sleeping (0-5 am), PDmax (maximal value obtained with each participant during the 0-24 h interval), PDmin (minimal value obtained with each participant during the 0-24 h interval), and PDmax/PDmin. PDmax/PDmim was calculated as the ratio of the PDmax to PDmin, and it showed the degree of change during the 0-24 h interval. The mean was adjusted for Baseline value.
Time Frame
Baseline and Week 8
Title
Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8
Description
The NYHA classification assesses the severity of symptoms of heart failure as judged by the investigator and is comprised of. 4 classes: I, no resulting limitations on physical activity (PA); II, slight limitations on PA; III, marked limitations on PA; IV, inability to carry out any PA without discomfort. The number of participants with any change from Baseline in the NYHA Functional Class at Week 8 was calculated. Improved=class at the visit is decreased compared to baseline class, Unchanged=class at the visit is stable, Worsened=class at the visit is increased compared to baseline class.
Time Frame
Baseline and Week 8
Title
Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8
Description
Brain natriuretic peptide is a surrogate marker of the severity of heart failure and was measured by a central laboratory.
Time Frame
Baseline and Week 8
Title
Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8
Description
Left ventricular ejection fraction (LVEF) is a marker of left ventricular systolic function and was measured by echocardiogram. It is shown as the ratio of left ventricular stroke volume (LVSV) to left ventricular end-diastolic volume (LVEDV), and is measured as a percentage.
Time Frame
Baseline and Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
296-8602
Country
Japan
Facility Name
GSK Investigational Site
City
Ehime
ZIP/Postal Code
794-0006
Country
Japan
Facility Name
GSK Investigational Site
City
Hiroshima
ZIP/Postal Code
737-0023
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Facility Name
GSK Investigational Site
City
Mie
ZIP/Postal Code
511-0068
Country
Japan
Facility Name
GSK Investigational Site
City
Nagano
ZIP/Postal Code
397-8555
Country
Japan
Facility Name
GSK Investigational Site
City
Nagasaki
ZIP/Postal Code
859-3615
Country
Japan
Facility Name
GSK Investigational Site
City
Oita
ZIP/Postal Code
879-5593
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
GSK Investigational Site
City
Saga
ZIP/Postal Code
843-0393
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
364-8501
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
410-2295
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
411-8611
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
427-8502
Country
Japan
Facility Name
GSK Investigational Site
City
Shizuoka
ZIP/Postal Code
430-8502
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
141-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
196-0003
Country
Japan
Facility Name
GSK Investigational Site
City
Wakayama
ZIP/Postal Code
640-8158
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
22240593
Citation
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;76(3):668-74. doi: 10.1253/circj.cj-11-0210. Epub 2012 Jan 12.
Results Reference
background
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
CRV110734
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
CRV110734
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
CRV110734
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
CRV110734
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
CRV110734
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
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