ObesityPhase 3RIALTONCT00458081
Evaluation of the Rimonabant Impact on the Regression of Asymptomatic Damage Caused by Cardiovascular Risk Factors
A Phase 3 study testing Rimonabant in people with Obesity and Microalbuminuria, run by Sanofi at 1 site in Spain.
Trial summary
Primary objective: To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period. Secondary objectives: Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Obesity, Microalbuminuria, Diabetes Mellitus, Type 2
- What is being tested?
- Rimonabant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2007to Jan 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index > 27 kg/m2 and < 40 kg/m2.
- Waist circumference > 102 cm in men and > 88 cm in women.
- Microalbuminuria >= 20 mg/g creatinine and < 300 mg/g creatinine in at least two of three morning urine samples taken on 3 separate days prior to the baseline visit.
- Type 2 diabetes and/or dyslipidaemia.
Who cannot join
- Breastfeeding or pregnant women or who expect to become pregnant.
- Non-use of approved methods of contraception in women of child-bearing potential.
- History of very low calorie diet in the 3 months prior to the screening visit (<1200 kcal/day).
- Change in weight > 5 kg in the 3 months prior to the screening visit.
- History of surgery for weight loss (such as vertical banded gastroplasty, gastric by-pass, etc.)
- History of bulimia or anorexia nervosa according to DSM-IV definition.
Show all 30Show fewer
- Any clinically significant endocrine disorder, in the opinion of the investigator, especially known alterations in the blood concentration of TSH and free T4.
- Type 1 Diabetes
- Triglyceridaemia > 400 mg/dl (4.52 mmol/l)
- Severe renal dysfunction
- Chronic Hepatitis or clinically known significant liver disease or ALT and/or AST > 3x the upper limit of the normal range at the screening visit.
- Hypertension at the screening visit.
- Presence of any condition (medical, including clinically significant abnormal laboratory tests, physiological, social or geographical) actual or anticipated that the investigator feels would compromise the patient's safety or limit his/her successful participation to the study.
- History of abuse of alcohol or other substances (except smoking).
- Hypersensitivity or intolerance to the active ingredient or any of the excipients, such as lactose.
- Concomitant medication prior to the screening visit
- Administration of any treatment undergoing clinical investigation (drug or medical device) in the 30 days prior to the screening visit.
- Previous treatment with rimonabant.
- Administration of any of the following products in the 3 months prior to the screening visit
- Anti-obesity drugs (such as, sibutramine or orlistat).
- Other weight loss drugs (phentermine,amphetamines).
- Weight loss herbal preparations.
- Nicotinic acid, fibrates, bile acid sequestrants or Omega 3 drugs (e.g. Omacor).
- Prolonged use (more than a week) of systemic corticosteroids or neuroleptics
- Antidepressants (including bupropion)
- Insulin, thiazolidinediones, α-glucosidase inhibitors, meglitinides or any group of antidiabetic drugs (except combination of biguanides and sulfonylureas)
- In type 2 diabetes patients, start of or change in treatment with sulfonylureas and/or metformin, in the 4 weeks prior to the screening visit.
- Start of or change in treatment with antihypertensive drugs in the 12 weeks prior to the screening visit.
- Start of or change in treatment with statins and/or ezetimibe in the 8 weeks prior to the screening visit.
- 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 12-month Multicentre, Randomised, Double-blind, Placebo-controlled Study With Two Parallel Groups to Assess the Effects of Rimonabant 20 mg in Patients With Abdominal Obesity and Microalbuminuria, With Type 2 Diabetes Mellitus or Dyslipidaemia With or Without Other Cardiometabolic Risk Factors.
Primary objective:
- To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period.
Read more
Secondary objectives:
- Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo.
- To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on:
- Weight and waist circumference.
- Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.
- Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B.
- Inflammatory markers
- Adipocytokines.
- Blood pressure.
- Glomerular filtration rate.
- To assess the quality of life by means of questionnaire filled in.
- Safety parameters
- Conditions
- Obesity, Microalbuminuria, Diabetes Mellitus, Type 2, Dyslipidemia
- Being tested
- Rimonabant, Placebo
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RimonabantDrug
20 mg once per day + slightly reduced calorie diet
PlaceboDrug
placebo once per day + slightly reduced calorie diet
| Study group | Role | What they receive |
|---|---|---|
| Rimonabant | Experimental | Not described Receives: Drug: Rimonabant |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in the microalbuminuria level.
Measured: between baseline visit and Month 12
Secondary outcomes (4)
Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered.
Measured: between baseline visit and Month 12
Relative change and absolute change of Weight, Waist circumference, Body mass index (weight and height), Specific lipid parameters, Glycaemia control parameters, Proinflammatory markers, Adipocytokines, Glomerular filtration rate, Blood pressure
Measured: between baseline visit and Month 12
Evaluation of the Quality of Life (questionnaire IWQOL).
Measured: at baseline visit and at 3, 6 and 12 months visit
Safety (including neuropsychiatric events) and Laboratory assessments.
Measured: at each visit and at baseline, 3, 6 and 12 month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Company decision has been taken in light of recent 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
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- José Mª Taboada, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458081
- Sponsor's protocol ID
- RIMON_L_01031
- Other IDs
- EudraCT # : 2006-002951-33
- Acronym
- RIALTO
- Status last verified
- Dec 2010
- First submitted
- 6 Apr 2007
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-month Multicentre, Randomised, Double-blind, Placebo-controlled Study With Two Parallel Groups to Assess the Effects of Rimonabant 20 mg in Patients With Abdominal Obesity and Microalbuminuria, With Type 2 Diabetes Mellitus or Dyslipidaemia With or Without Other Cardiometabolic Risk Factors.
- ClinicalTrials.gov ID
- NCT00458081
- Acronym / sponsor ID
- RIALTO / RIMON_L_01031
- Conditions
- Obesity, Microalbuminuria, Diabetes Mellitus, Type 2, Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company decision has been taken in light of recent demands by certain national health authorities
- Enrolment
- 174 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Apr 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.
Primary objective:
- To assess the effect on microalbuminuria levels of treatment with rimonabant 20 mg versus a placebo during a 12 month period.
Secondary objectives:
- Percentage of patients in both arms of the study whose levels of microalbuminuria decrease, stabilise, increase towards macroalbuminuria or are unchanged after 12 months of treatment with rimonabant or placebo.
- To assess the effect of treatment with rimonabant 20 mg versus placebo over a 12 month period on:
- Weight and waist circumference.
- Glycaemia profile: fasting glycaemia, fasting insulinaemia and HbA1c.
- Lipid and lipoprotein profile: triglycerides, total cholesterol, HDL-C, LDL-C, apolipoproteins A1 and B.
- Inflammatory markers
- Adipocytokines.
- Blood pressure.
- Glomerular filtration rate.
- To assess the quality of life by means of questionnaire filled in.
- Safety parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rimonabant | Experimental | Drug: Rimonabant |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index > 27 kg/m2 and < 40 kg/m2.
- Waist circumference > 102 cm in men and > 88 cm in women.
- Microalbuminuria >= 20 mg/g creatinine and < 300 mg/g creatinine in at least two of three morning urine samples taken on 3 separate days prior to the baseline visit.
- Type 2 diabetes and/or dyslipidaemia.
Key exclusion criteria (30 listed)
- Breastfeeding or pregnant women or who expect to become pregnant.
- Non-use of approved methods of contraception in women of child-bearing potential.
- History of very low calorie diet in the 3 months prior to the screening visit (<1200 kcal/day).
- Change in weight > 5 kg in the 3 months prior to the screening visit.
- History of surgery for weight loss (such as vertical banded gastroplasty, gastric by-pass, etc.)
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 |
|---|---|---|
| Rimonabant20 mg once per day + slightly reduced calorie diet | Drug | Rimonabant |
| Placeboplacebo once per day + slightly reduced calorie diet | Drug | Placebo |
Primary outcome
Relative change in the microalbuminuria level.
Time frame: between baseline visit and Month 12
4 secondary outcomes
Percentage of patients whose albuminuria levels decrease, stabilise, are progressing towards macroalbuminuria, are unaltered.
Time frame: between baseline visit and Month 12
Relative change and absolute change of Weight, Waist circumference, Body mass index (weight and height), Specific lipid parameters, Glycaemia control parameters, Proinflammatory markers, Adipocytokines, Glomerular filtration rate, Blood pressure
Time frame: between baseline visit and Month 12
Evaluation of the Quality of Life (questionnaire IWQOL).
Time frame: at baseline visit and at 3, 6 and 12 months visit
Safety (including neuropsychiatric events) and Laboratory assessments.
Time frame: at each visit and at baseline, 3, 6 and 12 month visits
Results and safety
The study was stopped early (reason given: Company decision has been taken in light of recent 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 10 Dec 2010.
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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.
José Mª Taboada 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 in people with Obesity and Microalbuminuria, run by Sanofi at 1 site in Spain.
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 4 inclusion and 30 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 10 Dec 2010. 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 Spain. 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 has been taken in light of recent 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?
Relative change in the microalbuminuria level. (time frame: between baseline visit and Month 12). 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 10 Dec 2010.