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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 (HOPETips)

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ClinicalTrials.gov Identifier: NCT03099213
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: RAMIPRIL HOE498 Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril

Arm Intervention/treatment
Experimental: 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.
Drug: RAMIPRIL HOE498
Pharmaceutical form:Tablet Route of administration: Oral




Primary Outcome Measures :
  1. Total patients with tolerability score Very Good [ Time Frame: 12 weeks ]
  2. Total patients with tolerability score Good [ Time Frame: 12 weeks ]
  3. Total patients with tolerability score Sufficient [ Time Frame: 12 weeks ]
  4. Total patients with tolerability score Insufficient [ Time Frame: 12 weeks ]
  5. Total patients with tolerability score Not Good [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of Adverse Events or Serious Adverse Events reported [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099213


Locations
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Indonesia
Sanofi Administrative Office
Bali, Indonesia
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03099213     History of Changes
Other Study ID Numbers: RAMIP_L_03123
U1111-1193-0859 ( Other Identifier: UTN )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents