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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

NCT03099213 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2022-04-25

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

RAMIPRIL HOE498

Pharmaceutical form:Tablet Route of administration: Oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-01
Primary Completion
2010-04-23
Completion
2010-04-23

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03099213 on ClinicalTrials.gov