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

A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03099213

Acronym

HOPETips

Enrollment

179

Registered

2017-04-04

Start date

2008-11-01

Completion date

2010-04-23

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief 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).

Detailed description

The duration of the study period is 8-12 weeks.

Interventions

DRUGRAMIPRIL HOE498

Pharmaceutical form:Tablet Route of administration: Oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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
Total patients with tolerability score Very Good	12 weeks
Total patients with tolerability score Good	12 weeks

Secondary

Measure	Time frame
Number of Adverse Events or Serious Adverse Events reported	12 weeks

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026