CTRI/2018/08/015555已完成不适用
A clinical assessment to evaluate the effect of two different combinations of anti-hypertensive drugs (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10 mg among Subjects with uncontrolled hypertension in India – A prospective, randomized, investigator initiated study.
Current Medical Concepts Pvt Ltd3 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- To evaluate the effect of two different treatments on BP levels in Subjects with Hypertension
研究概览
简要总结
This is an investigator initiated study to evaluate the effect of two different combinations of antihypertensive treatments that are already approved and marketed in India for so long. However, the current study is planned to evaluate the role of combination therapy on BP levels as per the new hypertension guidelines.
The drugs that will be used in this study are as follows: (Telmisartan 40 mg plus Amlodipine 5 mg and Telmisartan 40 mg plus Cilnidipine 10 mg)
This study is planned to be conducted across three centers with a sample size 100.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Adults greater than or equal to 18 years and less than or equal to 70 years old both male and female.
- •b) Subjects with uncontrolled BP who are on monotherapy.
- •c) Systolic Blood Pressure (SBP) >130 mmHg and Diastolic Blood Pressure (DBP) > 80 mmHg based on three consecutive blood pressure readings d) Any stage of Hypertension.
- •e) Willing to give written informed consent.
排除标准
- •a) Women of child bearing potential b) History of Myocardial infarction, Acute stroke, Acute kidney injury in the last 3 months c) Subjects with history of congestive heart failure.
- •d) Subjects with advanced CKD with Serum Creatinine value > 2.5 mg/dL.
- •e) History of allergy to calcium channel blockers and angiotensin receptor blockers f) Inability to give informed consent g) Subject with hypertensive crisis (Seated BP greater than or equal to 180/120 mmHg) on the day of screening.
- •h) Subjects unwilling/unable to adhere to the study protocol.
结局指标
主要结局
To evaluate the effect of two different treatments on BP levels in Subjects with Hypertension
时间窗: Screening and Week 8 (end of study)
次要结局
- To assess the safety and tolerability of combination therapy from baseline to end of study(Between Baseline to end of study)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Evaluation and Comparison of 2 Cosmetic Investigational Products in Adults With Atopic DermatitisAtopic DermatitisNCT03632174BioGaia AB36
已完成
2 期
Rotating Pazopanib and Everolimus to Avoid ResistanceClear Cell Renal CarcinomaNCT01408004Netherlands Working Group on Immunotherapy of Oncology101
已完成
3 期
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)Postoperative Nausea and VomitingNCT00090155Merck Sharp & Dohme LLC805
已完成
3 期
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)Postoperative Nausea and VomitingNCT00090246Merck Sharp & Dohme LLC922
Unknown
2 期
A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.Acute Ischemic StrokeNCT04028518Angde Biotech Pharmaceutical Co., Ltd.180