Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety
      of amlodipine besylate in subjects with newly diagnosed hypertension requiring
      antihypertensive therapy.

      This study was conducted to support a future marketing application for KIT-302. Kitov Pharma
      Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting
      of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory
      drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve
      patient compliance with the once a day (qd) administration of its individual components,
      amlodipine and celecoxib.

      The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a
      single immediate release tablet. However, for this study, two separate capsules were
      utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo
      capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched
      placebo tablet.

      The study hypothesis was that treatment with the amlodipine besylate containing capsule plus
      the celecoxib containing capsule would reduce blood pressure (BP) in subjects with
      hypertension with an efficacy that is not substantially inferior to the effect of amlodipine
      besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the
      celecoxib capsule).

      The United States (US) Food and Drug Administration (FDA) recently approved KIT-302, under
      the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA)
      210045] for the following indication: "patients for whom treatment with amlodipine for
      hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure
      reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and
      myocardial infarctions."
    


Intervention name(s): Over-encapsulated 10 mg amlodipine besylate tablet; Matched placebo capsule for over-encapsulated celecoxib capsule; Over-encapsulated 200 mg celecoxib capsule; Matched placebo capsule for over-encapsulated amlodipine besylate tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks; Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks; Over-encapsulated 200 mg celecoxib capsule once a day for two weeks; Matched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks
Other intervention name(s): Norvasc; Placebo; Celebrex; Placebo
Intervention MeSH terms: Celecoxib; Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High blood pressure; Systolic blood pressure; Diastolic blood pressure; Antihypertensive