Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)
Active, no longer recruiting
Phase of Trial: Phase IV
Latest Information Update: 04 Dec 2017
At a glance
- Drugs Aclidinium bromide (Primary)
- Indications Chronic obstructive pulmonary disease
- Focus Adverse reactions; Therapeutic Use
- Acronyms ASCENT; ASCENT COPD
- Sponsors Actavis; AstraZeneca; Forest Laboratories
- 04 Dec 2017 According to a Circassia media release, based on the results from this study AstraZeneca plans to submit an supplemental New Drug Application (sNDA) with the United States Food and Drug Administration (FDA) to request inclusion of the trial data in Tudorza's label.
- 04 Dec 2017 Top-line results published in the Circassia media release.
- 04 Dec 2017 Primary endpoint Rate of moderate or severe COPD exacerbations per patient per year during the first year of treatment has been met, according to a Circassia media release.