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)
|ClinicalTrials.gov Identifier: NCT03099213|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
To document the tolerability of patients receiving study medication at 12-week of therapy in terms of the scoring system assessed by the investigator.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: RAMIPRIL HOE498||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS|
|Study Start Date :||November 1, 2008|
|Actual Primary Completion Date :||April 23, 2010|
|Actual Study Completion Date :||April 23, 2010|
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.
Drug: RAMIPRIL HOE498
Pharmaceutical form:Tablet Route of administration: Oral
- Total patients with tolerability score Very Good [ Time Frame: 12 weeks ]
- Total patients with tolerability score Good [ Time Frame: 12 weeks ]
- Total patients with tolerability score Sufficient [ Time Frame: 12 weeks ]
- Total patients with tolerability score Insufficient [ Time Frame: 12 weeks ]
- Total patients with tolerability score Not Good [ Time Frame: 12 weeks ]
- Number of Adverse Events or Serious Adverse Events reported [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099213
|Sanofi Administrative Office|
|Study Director:||Clinical Sciences & Operations||Sanofi|