An Open-label, Non-comparative Study to Document the Tolerability to Ramipril in Patients With at Least One High Risk for Developing a Major Cardiovascular Event (HOPETips)
2022年4月22日 更新者:Sanofi
A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS
Primary Objective:
To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.
Secondary Objectives:
- To document drug safety at 12-week of treatment in terms of number of Adverse Drug Reaction or Serious Adverse Drug Reaction reported.
- To describe the population treated as per the HOPE study indication in current clinical practice (demographics, cardiovascular risk-factors at treatment initiation, concomitant treatments patterns).
研究概览
详细说明
The duration of the study period is 8-12 weeks.
研究类型
介入性
注册 (实际的)
179
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Bali、印度尼西亚
- Sanofi Administrative Office
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
55年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria :
- Man or woman, age 55 years old or more.
- Presence of a high risk of developing a major cardiovascular event, defined as at least one of the following underlying conditions:
- Clinical evidence of coronary artery disease (examples: previous myocardial infarction [MI], positive stress test or significant stenosis at coronary angiography, previous Percutaneous Trans-Luminal Coronary Angioplasty [PTCA], previous Coronary Arterial Bypass Grafting [CABG]);
- Clinical evidence of peripheral vascular disease (examples: history of intermittent claudication with positive Doppler or angiography, previous limb bypass surgery, previous percutaneous trans-luminal angioplasty, previous limb or foot amputation);
- Previous stroke;
- Diabetes (insulin-dependent or non-insulin dependent) with at least one of the following cardiovascular risk factors:
- hypertension (blood pressure [BP] >140/90 mmHg, or patients on antihypertensive treatment);
- hypercholesterolemia (total cholesterol > 5.2 mmol/L [>200 mg/dL]);
- low HDL cholesterol (< 0.9 mmol/L [<3.5 mg/dL]);
- current cigarette smoking;
- documented microalbuminuria (30-300 mg/24 hours);
- Evidence of previous vascular disease.
Exclusion criteria:
- Patients with contraindications to ramipril use (as per the local Ramipril Product Information)
- hypersensitivity
- pregnancy, lactation
- bilateral renal stenosis
- Patients with clinically relevant concomitant disease that could compromise the patient's safety or follow up.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Ramipril
Receiving ramipril with the recommended initial dose of 2.5 mg once daily; depending on the tolerability, the dose should be gradually increased.
The increase should be implemented by doubling the dose after one to two weeks.
Three or four weeks later, the dose should be doubled again up to the usual maintenance dose of 10 mg once daily.
|
Pharmaceutical form:Tablet Route of administration: Oral
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Total patients with tolerability score Very Good
大体时间:12 weeks
|
12 weeks
|
Total patients with tolerability score Good
大体时间:12 weeks
|
12 weeks
|
Total patients with tolerability score Sufficient
大体时间:12 weeks
|
12 weeks
|
Total patients with tolerability score Insufficient
大体时间:12 weeks
|
12 weeks
|
Total patients with tolerability score Not Good
大体时间:12 weeks
|
12 weeks
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Number of Adverse Events or Serious Adverse Events reported
大体时间:12 weeks
|
12 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年11月1日
初级完成 (实际的)
2010年4月23日
研究完成 (实际的)
2010年4月23日
研究注册日期
首次提交
2017年3月31日
首先提交符合 QC 标准的
2017年3月31日
首次发布 (实际的)
2017年4月4日
研究记录更新
最后更新发布 (实际的)
2022年4月25日
上次提交的符合 QC 标准的更新
2022年4月22日
最后验证
2022年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RAMIP_L_03123
- U1111-1193-0859 (其他标识符:UTN)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
RAMIPRIL HOE498的临床试验
-
October 6 UniversityBeni-Suef University; National Heart Institute, Egypt招聘中