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)

Trial Profile

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)

Discontinued
Phase of Trial: Phase IV

Latest Information Update: 01 Jun 2018

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
  • Most Recent Events

    • 01 Jun 2018 According to a Circassia media release, based on the results from this study, company announced the submission of a supplemental New Drug Application for Tudorza Pressair for the inclusion of clinical data demonstrating cardiovascular safety and reduction of COPD exacerbations in the product's prescribing information.
    • 01 Jun 2018 According to a Circassia media release, company announced the submission of a New Drug Application (NDA) to the United States Food and Drug Administration for Duaklir Pressair for the treatment of chronic obstructive pulmonary disease. The NDA is supported by the data from the AMPLIFY study, results from two previous Duaklir phase III studies, ACLIFORM and AUGMENT, and exacerbation data from the ASCENT trial.
    • 23 May 2018 Status changed to discontinued after more than or equal to 122 MACE had occurred (with a maximum study duration of 3 years) in order to achieve 90% power to rule out a hazard ratio (HR) of 1.8 in time to first MACE for aclidinium versus placebo. Non-inferiority was concluded if the upper bound of the 95% confidence interval was <1.8, as per the results presented at the 114th International Conference of the American Thoracic Society.
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