CTRI/2024/05/068049尚未招募4 期
Comparison of efficacy , safety and cost effectiveness of Amlodipine versusS-Amlodipine in patients with Grade I and grade II hypertension- aprospective, Randomised controlled trial , 16-weeks Double Blind study. - NI
Indira Gandhi Government Medical College and Hospital, Nagpur.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and female patients aged 18 to 75 years
- •2. Diagnosed with grade I & II hypertension ( Systolic BP between 140-179 mmHg and/or Diastolic BP between 90-109 mmHg).
- •3. Patients who are able to comply with the study protocol ,attend scheduled visits ,willingness to participate in the study and provide informed consent.
- •4. 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 .
- •5. Patient with known significant Neurological diseases , Coagulation disorders , metabolic or endocrine disorder (except Type 2 Diabetes Mellitus)
- •6. 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.
- •7. Patient with Liver or Kidney disorder
- •8. 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.
- •10. 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.
- •13. 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 .
- •15.Patients in inpatient department.
- •16. Known case of immunodeficiency
- •17.Age less than 18 years and greater than 75 years
- •18.Participation in another clinical trial.
研究者
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