Short-term Effects of Perindopril-amlodipine Versus Perindopril-indapamide on Blood Pressure Control in Newly Diagnosed Type 2 Diabetes Individuals With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 24-hour blood pressure
研究概览
简要总结
This was a double-blinded randomized controlled trial of 24-hour blood pressure control in sub Saharan type 2 diabetes patients, newly diagnosed for hypertension. They were allocated to receive either a fixed combination of perindopril + amlodipine or perindopril + indapamide for 42 days.
详细描述
This was a double-blinded randomized controlled trial conducted at the National Obesity Center and the cardiology unit of the Yaoundé Central Hospital in Cameroon from October 2016 to May 2017. Eligible patients were type 2 diabetes patients, newly diagnosed for hypertension (grade I or II) with confirmation on ambulatory BP monitoring (ABPM). Patients were either on lifestyle modification alone or on a stable anti-diabetic treatment for the past three months, aged 25-65 years naïve to any anti-hypertensive treatment, who provided their written informed consent. Participants were assigned to receive as anti-hypertensive treatment perindopril-amlodipine once daily or perindopril-indapamide at the same frequency. The two groups were followed up and monitored for sixth weeks and patients did not take any additional treatment with BP modifying properties.
The primary outcome was the relative change in circadian blood pressure profile between the two groups after six weeks of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult diabetes patients aged between 25-65 years,
- •with grade I or grade II (WHO classification) hypertension on the clinical measure, confirmed by ABPM
- •naïve to any anti-hypertensive treatment
- •written informed consent.
排除标准
- •Patients with grade III hypertension (WHO classification) were classified as hypertensive emergency,
- •estimated creatinine clearance ˂30ml/min/1.73m2 (using Modified Diet in Renal Diseases formula)
- •alanine transaminase (ALT)≥ 3 normal
- •any contraindication to study drugs (hypersensitivity)
- •pregnant or breastfeeding women
研究组 & 干预措施
Perindopril and Amlodipine
Fixed dose combination of Perindopril 5mg and Amlodipine 5mg tablets once daily for 6 weeks
干预措施: Perindopril and Amlodipine (Drug)
Perindopril-Indapamide
Fixed-dose combination of Perindopril 5mg and Indapamide 1.25mg tablets once daily for 6 weeks
干预措施: Perindopril-indapamide (Drug)
结局指标
主要结局
24-hour blood pressure
时间窗: 6 weeks
Change in average 24-hour blood pressure
次要结局
- night blood pressure dip(6 weeks)
研究者
Sobngwi Eugene
Medical Advisor
Yaounde Central Hospital