Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy

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."

Conditions

• Hypertension

Interventions

DRUG

Over-encapsulated 10 mg amlodipine besylate tablet

Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks

DRUG

Matched placebo capsule for over-encapsulated celecoxib capsule

Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks

DRUG

Over-encapsulated 200 mg celecoxib capsule

Over-encapsulated 200 mg celecoxib capsule once a day for two weeks

DRUG

Matched placebo capsule for over-encapsulated amlodipine besylate tablet

Matched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks

Sponsors & Collaborators

• Kitov Pharmaceuticals, Ltd.

  lead INDUSTRY

Principal Investigators

• J. Paul Waymack, MD, ScD · Kitov Pharma Ltd

• Brendan Colgan, MD · Celerion

• Claire Kightley, MB · Reading Clinical Research Aspect

• David Collier, MBBS, PhD, BSc · Barts Health NHS Trust, William Harvey Heart Centre, Barts & The London, Queen Mary School of Medicine and Dentistry, Queen Mary, University of London

• Paul Ivan, MBBS · Synexus Merseyside Clinical Research Centre

• Veronika Horvathova, MD · Synexus Scotland Clinical Research Centre

• Amit Mathew, MS, MBBS · Synexus Midlands Clinical Research Centre

• Alexander Thompson, MB, BS, DRCOG · Reading Clinical Research Aspect

• Mohamed Okily, MB · Synexus Manchester Clinical Research Centre

• Richard Gaunt, MB, ChB, MRCGP, DRCOG · Rowden Surgery

• Patrick Eavis, MBBS, DRCOG, DFFP, MRCGP · Oldfield Surgery

• Arjun Ravi, MBBS, MRCP · The Medicines Evaluation Unit Ltd.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-06-26

Primary Completion

2015-11-19

Completion

2015-11-19

Countries

• United Kingdom

Study Locations