A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects with Hypertension Requiring Antihypertensive Therapy

Trial Profile

A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects with Hypertension Requiring Antihypertensive Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2017

At a glance

  • Drugs Amlodipine (Primary) ; Celecoxib (Primary)
  • Indications Hypertension
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Kitov Pharmaceuticals
  • Most Recent Events

    • 02 Oct 2017 According to a Kitov Pharmaceuticals media release, U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for KIT-302, the FDA under the Prescription Drug User Fee Act (PDUFA), has set a target date of May 31, 2018 to complete its review.
    • 31 Jul 2017 According to a Kitov Pharmaceuticals media release, company has submitted a NDA to the U.S. FDA for KIT-302 and are on track to meet anticipated Prescription Drug User Fee Act (PDUFA) dates with respect to FDA filing the NDA in the third quarter of 2017, and rendering a decision on approval for marketing of KIT-302 during the second quarter of 2018
    • 26 Jun 2017 According to a Kitov Pharmaceuticals Holdings Ltd. media release, the company expects that the formal filing of the NDA by FDA will occur by the end of the third quarter of 2017.
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