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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1193-0859 | Other Identifier | UTN |
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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:
The duration of the study period is 8-12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramipril | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAMIPRIL HOE498 | Drug | Pharmaceutical form:Tablet Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total patients with tolerability score Very Good | 12 weeks | |
| Total patients with tolerability score Good | 12 weeks | |
| Total patients with tolerability score Sufficient | 12 weeks | |
| Total patients with tolerability score Insufficient | 12 weeks | |
| Total patients with tolerability score Not Good | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events or Serious Adverse Events reported | 12 weeks |
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Inclusion criteria :
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi Administrative Office | Bali | Indonesia |
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
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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