Evaluation of Celecoxib Effects on Amlodipine in Subjects With Existing Hypertension Requiring Antihypertensives
Status:
Completed
Trial end date:
2017-07-21
Target enrollment:
Participant gender:
Summary
The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety
of amlodipine besylate on renal and vascular function in subjects with existing hypertension
requiring antihypertensive therapy.
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 (KIT-302-03-02), commercial
celecoxib capsules (Celebrex®) and commercial amlodipine besylate tablets (Norvasc®) were
separately over-encapsulated (OE) and matched placebos were used to allow for blinding.
Kitov completed a phase 3 pivotal trial in subjects with newly diagnosed hypertension
(KIT-302-03-01) demonstrating that the amlodipine + celecoxib combination was statistically
non-inferior to amlodipine monotherapy with regard to reduction of blood pressure. Further,
trends towards superior blood pressure lowering effects and improved renal function were
observed for the combination. This study (KIT-302-03-02) was conducted to quantify the
beneficial renovascular effects noted in the prior study in subjects with existing
hypertension requiring antihypertensive therapy.
On May 31, 2018, the United States (US) Food and Drug Administration (FDA) 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."