CTRI/2022/04/042233尚未招募未知
A Prospective, Randomized, Double-blind, Double-dummy,Parallel-group,Investigator-initiated Study to Evaluate the Efficacy and Safety of Cilnidipine 10mg Tablet versus Amlodipine 10 mg Tablet in Patients with Newly DiagnosedHypertension
Dr Amey Beedkar0 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
- 未知
- 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. Adult male or female patients between 18 to 65 years (both agesinclusive).
- •2. Patients with newly diagnosed hypertension with blood pressuremore than or equal to 140/90 mmHg.
- •3. Serum creatinine within the normal range defined by the locallaboratory.
- •4. Patients willing to give their written informed consent to participatein the study.
- •5. Patients willing to comply with all aspects of the protocol.
排除标准
- •1. Blood pressure more than or equal to 180/110 mmHg.
- •2. Patients hypersensitive to active or inactive ingredients of investigational products.
- •3. Patients with uncontrolled diabetes mellitus at screening (uncontrolled defined as patients withHbA1c more than or equal to 8% with or without treatment).
- •4. Patients with recurrent symptomatic hypotension.
- •5. Patients with uncontrolled kidney disease requiring dialysis or renal replacement therapy.
- •6. Apparent/pseudo hypertension due to white coat effect, and medical inertia.
- •7. Patients with known history of heart failure, and reduce cardiac function.
- •8. Patients with concomitant causes of edema including, nephropathy, cardiac failure, hepatic cirrhosis, use of antidiabetic medications known to cause edema andhypoalbuminemia due to any other cause, will be excluded by renal and liver function tests, thyroid profile, and baseline echocardiography.
- •9. Patients with varicose veins.
- •10. Patients with nephrotic syndrome, hypoproteinemia, or microalbuminuria
- •11. Female patients who are pregnant, lactating, or planning to become pregnant.
- •12. Female patients not willing to use acceptable method of contraception.
- •13. History of clinically significant hematologic, hepatic, biliary obstructive disorders, neurologic(including extra pyramidal disorder), psychiatric, renal, cardiovascular(e.g. bradycardia, severe brady arrythmia, sick-sinus syndrome, atrioventricular block, malignant arrhythmia, severe coronary artery disease, unstable angina, vascular heart disease), endocrine, or other diseases or receiving any medication that, in the opinion of the investigator, would put the patient at risk through study period, or would affect the study analyses.
- •14. Patients scheduled to undergo surgery during the study period.
- •15. Patients who have received any intervention in a clinical trial within01 month prior to screening.
- •16. Patients with history of alcohol and/or drug/substance abuse and current significant alcohol consumption which as per investigators judgment, make the patient ineligible to participate in the study.
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