Cardiovascular DiseasePhase 3CRESCENDONCT00263042
Comprehensive Rimonabant Evaluation Study of Cardiovascular ENDpoints and Outcomes
A Phase 3 study testing Rimonabant in people with Cardiovascular Disease, run by Sanofi at 43 sites in 43 countries.
Trial summary
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Rimonabant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,695 participants
- Where
- 43 sitesin 43 countries
- Study dates
- Dec 2005to Apr 2009
- Phase
- Phase 3
- 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
- Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.
- CHD equivalents:
- Recent (within 3 years)documented heart attack
- Documented symptomatic coronary artery disease
- Recent (within 3 years) ischemic cerebrovascular episode (stroke or TIA)
- Documented symptomatic peripheral arterial disease
Show all 12Show fewer
- Major risk factors:
- Documented type 2 diabetes mellitus
- Metabolic syndrome (NCEP criteria)
- Asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair
- Elevated high-sensitivity C-reactive protein
- Age > or = 65 years for males, age > or = 70 years for females
Who cannot join
- Obesity of known endocrine origin
- Pregnant or breastfeeding women
- Very low calorie diet or weight loss surgery within past 6 months
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
- Likely cardiovascular intervention within next 1 month
- Allergy to rimonabant or excipients, or prior participation in a rimonabant trial
- Receipt of investigational product within past 30 days
Trial locations and contacts
43 sites in 43 countries.
43 sites in 43 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
Australia1 site
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales
About this study
Official title: Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.
The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
Read the detailed description
The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.
- Conditions
- Cardiovascular Disease
- Being tested
- Rimonabant, Placebo (for Rimonabant)
- Keywords
- Myocardial infarction, cerebrovascular accident, obesity
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Stroke, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
Also called SR141716, Acomplia
Tablet, oral administration
Placebo (for Rimonabant)Drug
Tablet, oral administration
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Rimonabant 20 mg once daily Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Placebo (for Rimonabant) once daily. Receives: Drug: Placebo (for Rimonabant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death
Measured: From randomization up to common study end date (33-50 months)
Secondary outcomes (2)
First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization
Measured: From randomization up to common study end date (33-50 months)
All-cause mortality
Measured: From randomization up to common study end date (33-50 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Company decision taken in light of demands by certain national health authorities
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18,695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Topol, MD, Study chair, Scripps ClinicDeepak L. Bhatt, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263042
- Sponsor's protocol ID
- EFC5826
- Other IDs
- 2005-002942-20, 2005
- Acronym
- CRESCENDO
- Status last verified
- Apr 2016
- First submitted
- 6 Dec 2005
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. doi: 10.1016/S0140-6736(10)60935-X.
PubMed 20709233Bhatia G, Bansal V, Harismendy O, Schork NJ, Topol EJ, Frazer K, Bafna V. A covering method for detecting genetic associations between rare variants and common phenotypes. PLoS Comput Biol. 2010 Oct 14;6(10):e1000954. doi: 10.1371/journal.pcbi.1000954.
PubMed 20976246
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multinational, Multicenter, Double-blind, Placebo-controlled, Two-arm Parallel Group Trial of Rimonabant 20 mg OD for Reducing the Risk of Major Cardiovascular Events in Abdominally Obese Patients With Clustering Risk Factors
- ClinicalTrials.gov ID
- NCT00263042
- Acronym / sponsor ID
- CRESCENDO / EFC5826
- Conditions
- Cardiovascular Disease
- Keywords
- Myocardial infarction, cerebrovascular accident, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 18,695 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Dec 2005 (estimated)
- 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.
The primary objective is to show whether rimonabant reduces the risk of a heart attack (MI), stroke, or death from an MI or stroke in patients with abdominal obesity with other cardiovascular (CV) risk factors.
The secondary objective is to show whether rimonabant reduces the risk of MI, stroke, CV death, or CV hospitalization in these patients.
Detailed description
The estimated study duration per patient is 36 to 53 months. All patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Experimental | Drug: RimonabantRimonabant 20 mg once daily |
| Placebo | Placebo comparator | Drug: Placebo (for Rimonabant)Placebo (for Rimonabant) 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)
- Waist circumference >102 cm (40 inches) males, >88 cm (35 inches) females, with one coronary heart disease (CHD) equivalent or two major risk factors for cardiovascular disease.
- CHD equivalents:
- Major risk factors:
Key exclusion criteria (7 listed)
- Obesity of known endocrine origin
- Pregnant or breastfeeding women
- Very low calorie diet or weight loss surgery within past 6 months
- Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness
- Likely cardiovascular intervention within next 1 month
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 |
|---|---|---|
| RimonabantAlso: SR141716, AcompliaTablet, oral administration | Drug | Rimonabant |
| Placebo (for Rimonabant)Tablet, oral administration | Drug | Placebo |
Primary outcome
First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death
Time frame: From randomization up to common study end date (33-50 months)
2 secondary outcomes
First occurrence of any of myocardial infarction, stroke, CV death, and CV hospitalization
Time frame: From randomization up to common study end date (33-50 months)
All-cause mortality
Time frame: From randomization up to common study end date (33-50 months)
Results and safety
The study was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Results publication: PubMed 20709233Topol EJ, Bousser MG, Fox KA, Creager MA, Despres JP, Easton JD, Hamm CW, Montalescot G, Steg PG, Pearson TA, Cohen E, Gaudin C, Job B, Murphy JH, Bhatt DL; CRESCENDO Investigators. Rimonabant for prevention of cardiovascular events (CRESCENDO): a randomised, multicentre, placebo-controlled trial. Lancet. 2010 Aug 14;376(9740):517-23. doi: 10.1016/S0140-6736(10)60935-X.
- Derived from this study: PubMed 20976246Bhatia G, Bansal V, Harismendy O, Schork NJ, Topol EJ, Frazer K, Bafna V. A covering method for detecting genetic associations between rare variants and common phenotypes. PLoS Comput Biol. 2010 Oct 14;6(10):e1000954. doi: 10.1371/journal.pcbi.1000954.
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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.
Eric Topol, MD study chair
Scripps Clinic
Deepak L. Bhatt, MD principal investigator
The Cleveland Clinic
43 sites in 43 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimonabant in people with Cardiovascular Disease, run by Sanofi at 43 sites in 43 countries.
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 7 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: stopped early, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Argentina, Australia, Austria, Belgium and 38 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Company decision taken in light of demands by certain national health authorities). Results are not available in the source record.
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?
First occurrence of any of myocardial infarction, stroke or cardiovascular (CV) death (time frame: From randomization up to common study end date (33-50 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263042, which also lists 2 linked publications.
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 20 May 2016.