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 being studied for the treatment of congestive heart failure. It has been evaluated in a clinical trial involving Japanese patients with chronic heart failure. The drug is in Phase 1 of clinical development and is not yet approved for any use.
SK&F-105517-D is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. The company conducted a clinical trial of this drug in Japan for the treatment of congestive heart failure.
SK&F-105517-D is in Phase 1 of clinical development. It has completed one Phase 1/II clinical trial in Japan, which enrolled 41 patients with chronic heart failure. The drug remains investigational and has not received regulatory approval.
SK&F-105517-D has been studied in one completed clinical trial, registered as NCT00742508. This was a Phase I/II study in Japanese patients with chronic heart failure, enrolling 41 participants. The trial was controlled and randomized, though not double-blind, and included both male and female patients aged 20 years and older.
SK&F-105517-D is the specific drug name used in clinical development. No alternative names have been reported for this compound. It is a small molecule being investigated for congestive heart failure, and no other designations have been associated with it in the available information.