CTRI/2024/05/068049尚未招募4 期
Comparison of efficacy , safety and cost effectiveness of Amlodipine versus S-Amlodipine in patients with Grade I and grade II hypertension- a prospective, Randomised controlled trial , 16-weeks Double Blind study.
Indira Gandhi Government Medical College and Hospital, Nagpur.1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年6月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Mean Change in the blood pressure at the end of 16 weeks
研究概览
简要总结
This study is a prospective, Randomised controlled trial , 16-weeks Double Blind study to Compare the efficacy , safety and cost effectiveness of Amlodipine versus S-Amlodipine in patients with Grade I and grade II hypertension .Subjects will be recruited in the Medicine outpatient Department of a tertiary care teaching hospital. Although several clinical trials comparing amlodipine and (S)-amlodipine have been done, the literature lacks with properly conducted trial comparing the efficacy, safety and cost effect between the two drugs in patients in Indian scenario.Hence this clinical trial is planned in central India with aim to fill the existing knowledge gap regarding the safety, efficacy, and cost-effectiveness of amlodipine and S-amlodipine in Indian Scenario. The study is approved by the Institutional Ethics committee and will be done according to the ICMR guidelines for Biomedical Research on Human subjects.04:06 PM
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients aged 18 to 75 years
- •Diagnosed with grade I & II hypertension ( Systolic BP between 140-179 mmHg and/or Diastolic BP between 90-109 mmHg).
- •Patients who are able to comply with the study protocol ,attend scheduled visits ,willingness to participate in the study and provide informed consent.
- •OutPatient Department.
排除标准
- •1.Previous History of myocardial infarction , PTCA , CABG, angina pectoris or cerebrovascular accidents in the last 6 months .
- •2.History of secondary or malignant hypertension 3.History of congestive cardiac failure , cardiac arrhythmias, any other abnormalities in ECG.
- •4.Patient with known significant respiratory conditions .
- •Patient with known significant Neurological diseases , Coagulation disorders , metabolic or endocrine disorder (except Type 2 Diabetes Mellitus)
- •Uncontrolled Diabetes Mellitus (fasting blood glucose more than 140 mg/dl ) or diabetic edema or Type 2 Diabetes Mellitus taking insulin or oral hypoglycemic drugs other than Metformin or sulfonylureas and more than one sulfonylureas.
- •Patient with Liver or Kidney disorder
- •Patients who may develop edema feet by concomitant drug at screening : a.
- •Drugs that constrict intra renal blood vessels (eg.
- •NSAIDS , Cyclosporine etc.) b.
- •Drugs that dilate arterioles (eg .vasodilators etc) c.
- •Drugs that increase sodium reabsorption in the kidneys (eg steroids) d.Drugs that damage capillaries (eg interleukins 2 ) e.
- •Glitazone based drugs for diabetes 9.Known Hypersensitivity to CCBs.
- •Patients with psychiatric disorder .
- •11.Those who are taking the drugs that may cause drug interactions.
- •a.Drugs that may change the plasma concentration of amlodipine (eg.CYP3A4 inducers -Rifampicin , St.johns wort) b.Drugs that may increase the antihypertensive action {(eg.
- •other antihypertensives -CCBs , Beta blockers , ACEi , ARBs, Alpha blockers , diuretics , Ntg ),(TCAs- Amitriptyline , desipramine, imipramine, nortriptyline, protriptyline, trimipramine ),nitrate formulations ,baclofen , pioglitazone , sildenafil etc.} c.
- •Systemic corticosteroids ( fluocinolone , triamcinolone) etc .
- •: Local steroid application allowed.
- •d.Drugs that may increase the inhibitory action of muscle contraction .( eg-antiarrhythmics -amiodarone, quinidine) etc.
- •e.Drugs that may cause ventricular spasms (eg.
- •intravenous administration of dantrolene and verapamil) f.Drugs that may increase the risk of hypotension (eg CYP3A4 inhibitors -clarithromycin ) etc.
- •12.Patients with a history of malignancy within the last 5 years.
- •Pregnant and lactating women or the women in the reproductive age group not practicing the effevtive means of contraception 14.Patients with known alcohol or drug abuse and any condition .
- •Known case of immunodeficiency 17.Age less than 18 years and greater than 75 years 18.Participation in another clinical trial.
结局指标
主要结局
Mean Change in the blood pressure at the end of 16 weeks
时间窗: Mean Change in the blood pressure will be estimated at baseline and 16 weeks
次要结局
- Recording of adverse event, if any, according to(the prescribed proforma issued by)
- Analyzing the cost-effective analysis of antihypertensive drug mentioned in the trial(cost effective analysis will be done at baseline & 16 weeks.)
研究者
Dhwani Patel
Indira Gandhi Government Medical College and Hospital, Nagpur
研究点 (1)
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