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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

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: 16 Oct 2018

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At a glance

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

    • 31 Aug 2018 Biomarkers information updated
    • 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.
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