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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2021

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At a glance

  • Drugs Amlodipine/celecoxib (Primary) ; Amlodipine; Celecoxib
  • Indications Hypertension
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Kitov Pharmaceuticals; Purple Biotech

Most Recent Events

  • 31 May 2018 U.S. Food and Drug Administration (FDA) has approved Consensi™ (amlodipine and celecoxib) oral tablets for treatment of osteoarthritis pain and hypertension, according to a Kitov Pharmaceuticals media release.
  • 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

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