Coronary Artery DiseasePhase 4HOPETipsNCT03099213
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 Phase 4 study testing RAMIPRIL HOE498 in people with Coronary Artery Disease, run by Sanofi at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- RAMIPRIL HOE498
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2008to 23 Apr 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS
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).
Read the detailed description
The duration of the study period is 8-12 weeks.
- Conditions
- Coronary Artery Disease
- Being tested
- RAMIPRIL HOE498
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAMIPRIL HOE498Drug
Pharmaceutical form:Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: RAMIPRIL HOE498 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total patients with tolerability score Very Good
Measured: 12 weeks
Total patients with tolerability score Good
Measured: 12 weeks
Total patients with tolerability score Sufficient
Measured: 12 weeks
Total patients with tolerability score Insufficient
Measured: 12 weeks
Total patients with tolerability score Not Good
Measured: 12 weeks
Secondary outcomes (1)
Number of Adverse Events or Serious Adverse Events reported
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Nov 2008
- Primary completion23 Apr 2010
- Study completion23 Apr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099213
- Sponsor's protocol ID
- RAMIP_L_03123
- Other IDs
- U1111-1193-0859
- Acronym
- HOPETips
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Patients Treated With Ramipril for Cardiovascular Risk Reduction The HOPE Tips: The HOPE Study Translated Into PracticeS
- ClinicalTrials.gov ID
- NCT03099213
- Acronym / sponsor ID
- HOPETips / RAMIP_L_03123
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2008
- Primary completion
- 23 Apr 2010 (actual)
- Study completion
- 23 Apr 2010 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ramipril | Experimental | Drug: RAMIPRIL HOE498Receiving 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAMIPRIL HOE498Pharmaceutical form:Tablet Route of administration: Oral | Drug | Ramipril |
Primary outcome
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
1 secondary outcome
Number of Adverse Events or Serious Adverse Events reported
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RAMIPRIL HOE498 in people with Coronary Artery Disease, run by Sanofi at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total patients with tolerability score Very Good (time frame: 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.