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

Information source: Kitov Pharmaceuticals, Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Over-encapsulated 10 mg amlodipine besylate tablet (Drug); Matched placebo capsule for over-encapsulated celecoxib capsule (Drug); Over-encapsulated 200 mg celecoxib capsule (Drug); Matched placebo tablet for over-encapsulated amlodipine besylate tablet (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Kitov Pharmaceuticals, Ltd.

Official(s) and/or principal investigator(s):
J. Paul Waymack, MD, ScD, Study Director, Affiliation: Kitov Pharmaceuticals, Ltd.
Brendan Colgan, MD, Principal Investigator, Affiliation: Celerion
Claire Kightley, MB, Principal Investigator, Affiliation: Aspect Clinical
David Collier, MBBS, PhD, BSc, Principal Investigator, Affiliation: 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, Principal Investigator, Affiliation: Synexus Merseyside Clinical Research Centre
Veronika Horvathova, MD, Principal Investigator, Affiliation: Synexus Scotland Clinical Research Centre
Amit Mathew, MS, MBBS, Principal Investigator, Affiliation: Synexus Midlands Clinical Research Centre
Alexander Thompson, MB, BS, DRCOG, Principal Investigator, Affiliation: Reading Clinical Research Ltd., Science & Technology Centre
Mohamed Okily, MB, Principal Investigator, Affiliation: Synexus Manchester Clinical Research Centre
Richard Gaunt, MB, ChB, MRCGP, DRCOG, Principal Investigator, Affiliation: Rowden Surgery
Patrick Eavis, MBBS, DRCOG, DFFP, MRCGP, Principal Investigator, Affiliation: Oldfield Surgery
Allan Frederick Reid, MB ChB, Principal Investigator, Affiliation: The Medicines Evaluation Unit Ltd.

Summary

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean change in average daytime (9:00 to 21:00) ambulatory systolic blood pressure (SBPday)

Incidence of adverse events

Secondary outcome:

Mean change in average 24-hour ambulatory systolic blood pressure (SBP24h)

Mean change in average night-time (01:00 to 06:00) ambulatory systolic blood pressure (SBPnight)

Mean change in average 24-hour ambulatory diastolic blood pressure (DBP24h)

Mean change in average daytime (9:00 to 21:00) ambulatory diastolic blood pressure (DBPday)

Mean change in average night-time (01:00 to 06:00) ambulatory diastolic blood pressure (DBPnight)

Plasma concentrations of amlodipine and celecoxib

Eligibility

Minimum age: 40 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Adult 40 to 75 years of age 2. Newly diagnosed hypertension that requires chronic pharmacological therapy. Specifically, the subject must meet both of the following criteria: 1. Resting systolic BP ≥140 mmHg and ≤179 mmHg (where resting is defined as supine for at least 10 minutes with minimal interaction) at Initial Screening Visit 2. SBPday >135 mmHg at Baseline Visit (Day 0) 3. Body Mass Index of 18. 5 to 34. 9 kg/m2 4. Healthy (other than hypertension) as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests 5. A negative pregnancy test at Screening 6. Both males and women of child bearing potential agree to use adequate contraceptive methods while on study (from Screening through final study visit) 7. Able to comprehend and sign an informed consent form Exclusion Criteria: 1. Resting systolic BP >179 mmHg or a resting diastolic BP >110 mmHg at Screening (where resting is defined as supine for at least 10 minutes with minimal interaction) or SBP24h >169 mmHg or DBP24h >110 mmHg at randomization 2. SBPday ≤135 mmHg at baseline (Day 0) 3. Weight <55 kg 4. Fragile health 5. Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of safety data 6. Current or recent history (within 4 weeks prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection 7. Current clinically significant viral infection 8. History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin 9. Major surgery within 4 weeks prior to Screening 10. Presence of a malabsorption syndrome possibly affecting drug absorption (e. g., Crohn's disease or chronic pancreatitis) 11. Active peptic ulceration or history of gastrointestinal bleeding 12. History of myocardial infarction, congestive heart failure, or stroke 13. Any current cardiovascular disease 14. History of psychotic disorder 15. History of alcoholism or drug addiction or current alcohol or drug use that, in the opinion of the Investigator, will interfere with the subject's ability to comply with the dosing schedule and study evaluations 16. History of any illicit drug use within one year prior to Screening 17. Positive drug screen at Screening 18. Current treatment or treatment within 30 days prior to first dose of study drugs with another investigational drug or current enrollment in another clinical trial 19. Current treatment or treatment within 30 days prior to first dose of study drugs with an NSAID or systemic corticosteroid 20. Known history of human immunodeficiency virus, hepatitis B, or hepatitis C 21. Known hypersensitivity to amlodipine or celecoxib 22. Known hypersensitivity to the inactive ingredients in the over-encapsulated study drugs 23. Asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors 24. Subjects who, in the opinion of the Investigator, are unable or unlikely to comply with the dosing schedule and study evaluations 25. Pregnant or lactating 26. Unable to correctly use ambulatory blood pressure monitor after instruction on its use 27. Subjects with Child-Pugh Class B or C cirrhosis; 28. Subjects currently taking a calcium channel blocker for any reason including angina. Subjects will not be withdrawn from these drugs to be enrolled in the trial 29. Creatinine clearance <50 ml/min as estimated by the Cockroft-Gault equation 30. Known cytochrome P450 2C9 poor metabolizer 31. Subjects with allergy or hypersensitivity to sulfonamides

Locations and Contacts

Synexus Midlands Clinical Research Centre, Birmingham B15 2SQ, United Kingdom; Terminated

Synexus Scotland Clinical Research Centre, Glasgow G20 0SP, United Kingdom; Terminated

Barts Health NHS Trust, William Harvey Heart Centre, Barts & The London, Queen Mary School of Medicine and Dentistry, Queen Mary, University of London, London EC1M 6BQ, United Kingdom; Recruiting
David Collier, MBBS, PhD, BSc, Phone: +44 (0)2078825657, Email: d.j.collier@qmul.ac.uk
Anne Zak, Phone: +44 (0)2078825657, Email: a.zak@qmul.ac.uk
David Collier, MBBS, PhD, BSc, Principal Investigator

Synexus Manchester Clinical Research Centre, Manchester M15 6SX, United Kingdom; Withdrawn

Reading Clinical Research Ltd, Science & Technology Centre, Reading RG6 6BZ, United Kingdom; Recruiting
Dawn Mattingly, Phone: +44 118 935 7067, Email: enquiries@readingclinical.co.uk
Mariam Habib, Phone: +44 118 935 7067, Email: mh@readingclinical.co.uk
Alexander Thompson, MB, BS, DRCOG, Principal Investigator

Celerion, Belfast, Antrim BT9 6AD, United Kingdom; Recruiting
Amanda Mullen, Phone: +44 (0)2890554009, Email: Belfast.studies@celerion.com
Sean Finnegan, Phone: +44 (0)2890554089, Email: Belfast.studies@celerion.com
Brendan Colgan, MD, Principal Investigator

The Medicines Evaluation Unit Ltd., Manchester, Greater Manchester M23 9QZ, United Kingdom; Recruiting
Simon Pearson, Phone: +44 161 946 4077, Email: spearson@meu.org.uk
Allan Frederick Reid, MB ChB, Principal Investigator

Aspect Clinical, Ledbury, Herefordshire HR8 2AA, United Kingdom; Recruiting
Gemma Cunningham, Phone: +44 (0)1531637400, Email: aspect.clinical@aspectclinical.com
Megan Tustin, Phone: +44 (0)1531637400, Email: aspect.clinical@aspectclinical.com
Claire Kightley, MB, Principal Investigator

Synexus Merseyside Clinical Research Centre, Liverpool, Merseyside L22 0LG, United Kingdom; Terminated

Oldfield Surgery, Bath, North East Somerset BA2 3HT, United Kingdom; Recruiting
Patrick Eavis, Phone: +44 1225 423250, Email: patrick.eavis@nhs.net
Hayley Derbyshire, Phone: +44 1225 423250, Email: hayleyderbyshire@nhs.net
Patrick Eavis, MBBS, DRCOG, DFFP, MRCGP, Principal Investigator

Rowden Surgery, Chippenham, Wiltshire SN15 2SB, United Kingdom; Recruiting
Joanne Thomas, Phone: +44 1249 652086, Email: Joanne.thomas11@nhs.net
Gail Haughton, Phone: +44 1249 652086, Email: Gail.haughton@nhs.net
Richard Gaunt, MB, ChB, MRCGP, DRCOG, Principal Investigator

Additional Information

Starting date: June 2014
Last updated: June 13, 2015

Page last updated: August 23, 2015

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