Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SK&F-105517-D · 1 trial · 1 indication
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 was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
Mean change from baseline was calculated as the Week 8 value minus the Baseline value
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 was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Dipstick test values: Negative (-), Traces (+-), +1, +2, +3. +4. Normal ranges (qualitative): protein, - or +-; glucose, - or +-; occult blood, -; ketones, -.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
Mean change from baseline was calculated as the Week 8 value minus the Baseline value.
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 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.
| Arm | Type | Description |
|---|---|---|
| SK&F-105517-D group | EXPERIMENTAL | SK\&F-105517-D 10-80 mg/day |
| Carvedilol-IR group | OTHER | Carvedilol-IR 5-20 mg/day |
| Name | Type | Description |
|---|---|---|
| SK&F-105517-D 10 mg capsule | DRUG | 1 capsule once a day |
| Carvedilol-immediate release (IR) 2.5 mg tablet | DRUG | 1 or 2 tablet(s) twice a day |
| SK&F-105517-D 20 mg capsule | DRUG | 1 capsule once a day |
| SK&F-105517-D 40 mg capsule | DRUG | 1 or 2 capsule(s) once a day |
| Carvedilol-IR 10 mg tablet | DRUG | 1 tablet twice a day |
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) ...
SK&F-105517-D is an investigational small molecule developed by GSK plc for congestive heart failure. It is in Phase 1 clinical development and has been studied in a single completed trial of 41 patients in Japan. It is not an approved therapy.
SK&F-105517-D is being studied for the treatment of congestive heart failure. Its only clinical trial enrolled 41 Japanese patients with chronic heart failure. The drug remains investigational and is not approved for any indication.
SK&F-105517-D is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase I/II study of the compound in Japanese patients with chronic heart failure.
SK&F-105517-D is in Phase 1 development. One Phase I/II trial has been completed, and no trials are currently active. The compound has not received FDA approval and remains investigational for congestive heart failure.
SK&F-105517-D has been evaluated in one completed trial, NCT00742508, titled A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure. The randomized, controlled study enrolled 41 patients in Japan and is no longer recruiting.