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

PHASE3CompletedINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

June 26, 2014

Primary Completion Date

November 19, 2015

Study Completion Date

November 19, 2015

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

Trial Locations (10)

BT9 6AD

Celerion, Belfast

M23 9QZ

The Medicines Evaluation Unit Ltd., Manchester

HR8 2AA

Reading Clinical Research Aspect, Ledbury

L22 0LG

Synexus Merseyside Clinical Research Centre, Liverpool

BA2 3HT

Oldfield Surgery, Bath

SN15 2SB

Rowden Surgery, Chippenham

B15 2SQ

Synexus Midlands Clinical Research Centre, Birmingham

G20 0SP

Synexus Scotland Clinical Research Centre, Glasgow

EC1M 6BQ

Barts Health NHS Trust, William Harvey Heart Centre, Barts & The London, Queen Mary School of Medicine and Dentistry, Queen Mary, University of London, London

RG6 6BZ

Reading Clinical Research Aspect, Reading

Sponsors
All Listed Sponsors
lead

Kitov Pharmaceuticals, Ltd.

INDUSTRY