跳至主要内容
临床试验/NCT00742508
NCT00742508已完成1 期

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)

GlaxoSmithKline1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2008年8月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
41
试验地点
1
主要终点
Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

研究组 & 干预措施

SK&F-105517-D group

Experimental

SK&F-105517-D 10-80 mg/day

干预措施: SK&F-105517-D 10 mg capsule (Drug)

SK&F-105517-D group

Experimental

SK&F-105517-D 10-80 mg/day

干预措施: SK&F-105517-D 20 mg capsule (Drug)

SK&F-105517-D group

Experimental

SK&F-105517-D 10-80 mg/day

干预措施: SK&F-105517-D 40 mg capsule (Drug)

Carvedilol-IR group

Other

Carvedilol-IR 5-20 mg/day

干预措施: Carvedilol-immediate release (IR) 2.5 mg tablet (Drug)

Carvedilol-IR group

Other

Carvedilol-IR 5-20 mg/day

干预措施: Carvedilol-IR 10 mg tablet (Drug)

结局指标

主要结局

Number of Participants With Adverse Events by Severity From Week 0 Through Week 8 (CRV-IR) or Week 14 (SK&F-105517-D)

时间窗: 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

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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: Baseline and 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

时间窗: 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

时间窗: 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.

次要结局

  • Maximum Plasma Concentration (Cmax) and Trough Plasma Concentration (Cmin) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8(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(Week 8)
  • Time of Maximal Plasma Concentration (Tmax) of S-carvedilol, R-carvedilol, and M4 Active Metabolite (SB-203231) at Week 8(Week 8)
  • Adjusted Mean Change From Baseline in Systolic Blood Pressure at Week 8(Baseline and Week 8)
  • Adjusted Mean Change From Baseline in Diastolic Blood Pressure at Week 8(Baseline and Week 8)
  • Adjusted Mean Change From Baseline in Mean Heart Rate at Week 8(Baseline and Week 8)
  • Number of Participants With the Indicated Change From Baseline New York Heart Association (NYHA) Functional Class at Week 8(Baseline and Week 8)
  • Mean Plasma Brain Natriuretic Peptide Concentration at Baseline and Week 8(Baseline and Week 8)
  • Echocardiogram Results: Left Ventricular Ejection Fraction at Baseline and Week 8(Baseline and Week 8)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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