ObesityPhase 3NCT00434096
Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)
A Phase 3 study testing rimonabant (SR141716) in people with Obesity, run by Sanofi at 1 site in Japan.
Trial summary
The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks. Secondary objectives are: To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- rimonabant (SR141716)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 915 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2007to Feb 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) > 25 kg/m²
- Visceral Fat Area (VFA) > 100 cm²
- Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)
- At least 1 criteria of the following 2 comorbidities:
- Impaired Glucose Tolerance or Type 2 diabetes
- Hypertension
Who cannot join
- Patient with a secondary obesity.
- Patients who have received the diet therapy for less than 8 weeks before start of the observation period.
- Patients whose body weight changed by more than the variation of ± 2kg for screening period.
- Low compliance to drug intake (< 80%) and dietary instruction during the observation period.
- Patients with type 1 diabetes.
- Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).
- Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -4.
- Patients with a secondary hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.
The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.
Secondary objectives are:
- To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.
- To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.
- To evaluate the pharmacokinetics of SR141716.
- Conditions
- Obesity
- Being tested
- rimonabant (SR141716), placebo
- Keywords
- Obesity disease, cannabinoid-1 receptor
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rimonabant (SR141716)Drug
oral administration once daily
placeboDrug
oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: rimonabant (SR141716) |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight: relative change from baseline
Measured: Week 52
triglycerides: relative change from baseline
Measured: Week 52
Secondary outcomes (2)
HDL-cholesterol ;visceral fat area
Measured: Week 52
Safety: Adverse events
Measured: study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
- Study completionFeb 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.
- Other trials for ObesityStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 915 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434096
- Sponsor's protocol ID
- EFC5749
- Status last verified
- Jul 2009
- First submitted
- 9 Feb 2007
- Last updated
- 20 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.
- ClinicalTrials.gov ID
- NCT00434096
- Acronym / sponsor ID
- EFC5749
- Conditions
- Obesity
- Keywords
- Obesity disease, cannabinoid-1 receptor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision taken in light of demands by certain national health authorities
- Enrolment
- 915 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Feb 2007 (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 of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.
Secondary objectives are:
- To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.
- To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.
- To evaluate the pharmacokinetics of SR141716.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: rimonabant (SR141716) |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body Mass Index (BMI) > 25 kg/m²
- Visceral Fat Area (VFA) > 100 cm²
- Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)
- At least 1 criteria of the following 2 comorbidities:
Key exclusion criteria (8 listed)
- Patient with a secondary obesity.
- Patients who have received the diet therapy for less than 8 weeks before start of the observation period.
- Patients whose body weight changed by more than the variation of ± 2kg for screening period.
- Low compliance to drug intake (< 80%) and dietary instruction during the observation period.
- Patients with type 1 diabetes.
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 |
|---|---|---|
| rimonabant (SR141716)oral administration once daily | Drug | 1 |
| placebooral administration once daily | Drug | 2 |
Primary outcome
body weight: relative change from baseline
Time frame: Week 52
triglycerides: relative change from baseline
Time frame: Week 52
2 secondary outcomes
HDL-cholesterol ;visceral fat area
Time frame: Week 52
Safety: Adverse events
Time frame: study period
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 Jul 2009.
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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.
ICD CSD 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 3 study testing rimonabant (SR141716) in people with Obesity, run by Sanofi at 1 site in Japan.
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 6 inclusion and 8 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 Jul 2009. 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 Japan. 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?
body weight: relative change from baseline (time frame: Week 52). The study lists 2 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 20 Jul 2009.