Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AndroGel 5 Grams · 1 trial · 1 indication
Treadmill exercise testing performed according to the Bruce protocol (MAX-1 Marquette advanced exercise system, software version 002E). The system analyzed the signal averaged ECG and produces a graphical display of the level of the ST segment 80 ms after the J point against time. Time to 1 mm ST depression was measured from computer derived analysis, effectively eliminating observer bias.
Exercise capacity was measured using exercise time.
| Arm | Type | Description |
|---|---|---|
| Androgel treatment | EXPERIMENTAL | Androgel 5 grams Androgel treatment - subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months. |
| Placebo | PLACEBO_COMPARATOR | Placebo - will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months. |
| Name | Type | Description |
|---|---|---|
| AndroGel 5 Grams | DRUG | Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo. Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months. |
| Placebo | DRUG | Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo. Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months. |
Inclusion Criteria: * Adult male patients with coronary artery disease (CAD) (one to three vessel diseased). * Stable cardiac status at least 3 months after percutaneous coronary intervention (PCI). * No change in cardiac medications for 4 weeks prior to enrollment. * Testosterone \< 300 ng/dl or f...
AndroGel 5 Grams is a small molecule being studied for use in men with low testosterone levels who have Coronary Artery Disease after successful intervention of a blocked or narrowed heart artery. It is an investigational drug in Phase 3 clinical development, not yet approved for this indication.
AndroGel 5 Grams is a testosterone replacement therapy. It works by supplementing testosterone levels in men with low testosterone. The drug is being evaluated for its cardiac benefit in patients with Coronary Artery Disease.
AndroGel 5 Grams is developed by Abbott Laboratories, a company traded under the ticker ABT. The drug is currently in Phase 3 clinical development for Coronary Artery Disease.
AndroGel 5 Grams is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. One Phase 3 trial has been completed for its use in Coronary Artery Disease.
AndroGel 5 Grams has one completed clinical trial, NCT00413244, titled 'The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery.' This Phase 3 trial enrolled 51 male participants in the United States.
AndroGel 5 Grams is a testosterone replacement product. It is designed to deliver testosterone to men with low levels. The drug is being studied for its potential cardiac benefits in patients with Coronary Artery Disease.