Study Reference KIT-302-03-02
Research type
Research Study
Full title
A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine on Renal and Vascular Function in Subjects with Existing Hypertension Requiring Antihypertensive Therapy
IRAS ID
201698
Contact name
David Collier
Contact email
Sponsor organisation
Kitov Pharmaceuticals Ltd
Eudract number
2016-002214-47
Duration of Study in the UK
0 years, 6 months, 12 days
Research summary
Non‐steroidal anti‐inflammatory drugs (NSAIDs) are the worlds most widely consumed class of drugs. This is probably due to their known ability to reduce pain. However, it has recently been determined that they can raise blood pressure and increase the risk of heart attack, stroke and death in some people.
NSAIDs are frequently used to treat osteoarthritis, a disease that affects approximately half of all Western adults over age 50. In addition, over half of all Western patients over the age of 50 suffer from hypertension, a disease that increases the risk of heart attack, stroke and death.
Given these facts, the sponsor of this study is attempting to develop a combination drug product of amlodipine (a drug used to lower blood pressure) and celecoxib (a NSAID), that will treat the pain of osteoarthritis, while simultaneously lowering blood pressure.
The primary objective of the study is to quantify the differences in blood pressure control after oral administration of amlodipine and celecoxib, given together or alone, for 14 days in adult subjects with hypertension.
Approximately 105 adult subjects with Hypertension will be randomised to 1 of 3 treatment arms for 14 days:
10mg amlodipine + 200mg celecoxib
10mg amlodipine + matched placebo for celecoxib
Matched placebo for amlodipine + matched placebo for celecoxib
Subjects will be required to stop taking their routine blood pressure medication for up to 2 weeks during a washout period and during the 2 week treatment period. They will be asked to attend the clinic for 8 study visits over a 6 week period, during which time their blood pressure will be closely monitored. At the end of the 14 day treatment period, subjects will be treated as deemed appropriate by their study doctor or General Practitioner. Following a 14 day follow up period, subject’s study participation will be complete.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0376
Date of REC Opinion
23 Sep 2016
REC opinion
Further Information Favourable Opinion