Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
The purpose of this study is to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with hypertension requiring antihypertensive therapy.
This study is being conducted to support a future marketing application for KIT-302, an oral fixed combination drug product (FCDP) consisting of the antihypertensive drug amlodipine besylate and the non-steroidal anti-inflammatory drug (NSAID) celecoxib.
KIT-302 is being developed as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day administration of its individual components, amlodipine and celecoxib, when used together for the treatment of hypertension in patients who also require the use of an NSAID for relief of the signs and symptoms of osteoarthritis.
Although the final KIT-302 formulation will be a single capsule, for this study, two separate capsules will be 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 is that treatment with the amlodipine besylate containing capsule plus the celecoxib containing capsule will 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).
Study Type: Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Enrollment: 150
Study Start Date: June 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
- Experimental: Amlodipine+Celecoxib
- Active Comparator: Amlodipine+Placebo
- Placebo Comparator: Placebo+Celecoxib
- Sham Comparator: Placebo+Placebo
|Study start date||2014-06-20|