Evaluation of clinical acceptability of the Fixed Dose Combination of Perindopril + Indapamide in moderate to severe hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- The blood pressure reduction rates from baseline to the end of study with the treatment of the FDC of Perindopril + Indapamide
研究概览
简要总结
The available clinical evidence today provides the guidelines to initiate the two-drug therapy in patients with moderate to severe hypertension (Systolic BP above 160 mmHg and / or Diastolic BP above 100 mmHg). The fixed dose combination of Perindopril erbumine + Indapamide is marketed worldwide including India by the sponsor of this study under the brand name COVERSYL®PLUS. It is a well-accepted and well prescribed product for the treatment of hypertension. The recent introduction of higher strength of this combination is being evaluated in terms of its clinical acceptability in the proposed phase IV study.
This higher strength of the FDC of Perindopril 8 mg + Indapamide 2.5 mg is marketed under the trade name COVERSYL® PLUS HD (approved by the authorities in the year 2014). In this proposed study, the aim of the study is to evaluate the clinical acceptability of the higher strength of the FDC of Perindopril 8mg + Indapamide 2.5 mg in the treatment of hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mm Hg 2.Patients of either sex with age group of 18 to 65 years of age 3.Uncontrolled hypertensive patients with a baseline blood pressure > 140/90 mmHg on monotherapy and/or any other two drug FDC 4.Newly diagnosed hypertensive patients with h/o diabetes wherein tighter BP control is targeted (140/85 mm Hg) 5.Hypertensive patients either on monotherapy / any other FDC with h/o diabetes wherein tighter BP control is targeted (140/85 mm Hg) 6.Patients of either sex with confirmed diagnosis of grade II and above (moderate to severe) hypertension, as per ESC guidelines 7.Ready to provide informed consent and available for follow-up.
排除标准
- •1.H/o myocardial infarction within the previous 3 months.
- •2.H/o cerebrovascular event within previous 3 months.
- •3.Uncontrolled arrhythmias.
- •4.Uncontrolled diabetes (Hba1c% more than 7) 5.H/o heart failure 6.Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders 7.Patients unwilling to give informed consent 8.Patients with history of hypersensitivity to Perindopril or Indapamide 9.Any contraindication to ACE I and/or Thiazide type diuretic 10.Patients receiving beta blockers for the treatment of hypertension 11.Pregnancy or lactation 12.Patients with any other condition or disease, which in the opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant 13.Patients previously enrolled in similar trial in the last 3 months.
结局指标
主要结局
The blood pressure reduction rates from baseline to the end of study with the treatment of the FDC of Perindopril + Indapamide
时间窗: DAY 90
Mean decrease in blood pressure from the baseline in terms of achieving target BP control ≤140/90 mmHg (among diabetic patients ≤140/85 mmHg as per ESH/ESC 2013 guidelines).
时间窗: DAY 90
次要结局
- ²Tolerability and acceptability of the treatment in terms of incidence of side effects and treatment compliance(DAY 15 AND DAY 90)