EUCTR2016-002214-47-GB进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
相似试验
进行中（未招募）
1 期
A study to quantify any differences in blood pressure control after oral administration of amlodipine (a drug to treat high blood pressure) and celecoxib (a non steroidal anti inflammatory drug) given together or alone, once daily, in adult patients with newly diagnosed hypertension.HypertensionEUCTR2013-005381-19-GBKitov Pharmaceuticals Ltd
进行中（未招募）
3 期
Evaluate the Efficacy and Safety of Dose for cholesterolTM (Dietary supplement) and assess the effect of Dose for CholesterolTM on Cholesterol levels in healthy adults.CTRI/2024/05/066945EETHO BRANDS INC
已完成
2 期
A randomised placebo-controlled study of lovastatin in children with neurofibromatosis type 1Neurofibromatosis type 1eurofibromatosis type 1Neuropsychological impairmentHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersACTRN12607000560493Prof Kathryn North142
暂停
不适用
To study the effect of Tofacitinib along with corticosteroids in patients with acute severe ulcerative colitis.CTRI/2022/08/044613Dr Ajit Sood
招募中
不适用
A prospective, randomized placebo-controlled study of cryotherapy or placebo for prevention of oral mucositis (stomatitis) in patients with multiple myeloma undergoing autologous stem cell transplantation following high dose melphalaKCT0003949The Catholic University of Korea, Seoul St. Mary's Hospital40