A study to quantify any differences in blood pressure control and kidney function after oral administration of amlodipine (a drug to treat high blood pressure) and celecoxib (a non steroidal anti inflammatory drug) given together or amlodipine alone, once daily, in adult patients with high blood pressure.
- Conditions
- HypertensionMedDRA version: 19.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2016-002214-47-GB
- Lead Sponsor
- Kitov Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 105
1.Adult 40 to 75 years of age;
2.Existing hypertension that is being treated using pharmacological therapy with a single agent that is not a calcium channel blocker;
3.SBPday > 135 and = 169 mmHg and DPBday = 110 mmHg at Day 0 (i.e., after the 10 to 14 day washout from prior BP medication);
4.Body Mass Index (BMI) of 18.5 to 34.9 kg/m2;
5.Healthy (other than hypertension) as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests;
6.A negative pregnancy test at initial screening visit;
7.If WCBP, agree to use a highly effective form of birth control while on study (from Screening through final study visit);
Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Forms of birth control include intrauterine device (IUD), birth control patch or vaginal ring, oral, or injectable or implanted contraceptives, or a vasectomized partner, or abstinence from sexual intercourse. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
A woman that is postmenopausal (=2 years since last menstrual period) or permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP.
8.Able to comprehend and sign an ICF.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1.Resting systolic BP > 169 mmHg or a resting diastolic BP > 110 mmHg at initial screening visit while on their standard antihypertensive therapy (where resting is defined as supine for at least 10 minutes with minimal interaction);
2.Weight < 55 kg;
3.Fragile health;
4.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;
5.Current or recent history (within four weeks prior to initial screening visit) of a clinically significant bacterial, fungal, or mycobacterial infection;
6.Current clinically significant viral infection;
7.History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin;
8.Major surgery within four weeks prior to initial screening visit;
9.Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohn’s disease or chronic pancreatitis);
10.Active peptic ulceration or history of gastrointestinal bleeding;
11.History of myocardial infarction, congestive heart failure, or stroke;
12.Any current cardiovascular disease;
13.History of psychotic disorder;
14.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;
15.History of any illicit drug use within one year prior to initial screening visit;
16.Positive drug screen at initial screening visit. A positive drug screen for opiates only (with all other drug tests negative) will not be a basis for exclusion if the subject took over-the-counter narcotics as indicated on the product label within 24 hours prior to the drug screen;
17.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;
18.Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
19.Known hypersensitivity to amlodipine or celecoxib;
20.Known hypersensitivity to the inactive ingredients in the OE study drugs;
21.Asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 (COX-2) inhibitors;
22.Subjects who, in the opinion of the Investigator, are unable or unlikely to comply with the dosing schedule and study evaluations;
23.Pregnant or lactating;
24.Unable to correctly use ABPM after instruction on its use;
25.Subjects with Child-Pugh Class B or C cirrhosis;
26.Subjects currently taking a calcium channel blocker or any NSAID for any reason will be excluded. Subjects will not be withdrawn from these drugs to be enrolled in the trial;
27.Creatinine clearance < 50 ml/min as estimated by the Cockroft-Gault equation;
28.Known cytochrome P450 2C9 (CYP2C9) poor metabolizer;
29.Subjects with allergy or hype
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method