ObesityPhase 3SCOUTNCT00234832

A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients

A Phase 3 study testing Sibutramine hydrochloride in people with Obesity, run by Abbott at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event. Read more about this study

Who is it for?: Ages 55 years and older
Conditions the study is for: Obesity
What is being tested?: Sibutramine hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10,777 participants
Where: 1 siteUnited States
Study dates: Jan 2003to Nov 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subject's body mass index (BMI) was >= 27 kg/m(2) and <= 45 kg/m(2) or their BMI was >= 25 kg/m(2) and < 27 kg/m(2) with waist circumference of >= 102 cm in males or >= 88 cm in females.
Medical history positive for:
Preexisting cardiovascular disease (i.e., coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease) and/or
Type 2 diabetes mellitus with at least 1 other risk factor (i.e., dyslipidemia, controlled hypertension, current smoker, or diabetic nephropathy with evidence of microalbuminuria)

Who cannot join

History of recent myocardial infarction.
Heart failure symptoms greater than New York Heart Association Functional Class II.
Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
Subjects without a pacemaker and with any of the following:
Sinus bradycardia (< 50 bpm)
Sick sinus syndrome

Show all 18Show fewer

Atrioventricular block of more than 1st degree
Mean sitting systolic blood pressure (SBP) > 160 mmHg. Mean sitting diastolic blood pressure (DBP) > 100 mmHg. Mean sitting heart rate (HR) > 100 bpm.
Syncopal episodes presumed to be due to uncontrolled life-threatening arrhythmias.
Planned cardiac surgery or coronary angioplasty within 6 months of screening.
History of recent non-hemorrhagic stroke or transient ischemic attack (TIA), history of hemorrhagic stroke.
Hyperthyroidism.
Known chronic liver disease or endstage renal disease.
Severe, symptomatic benign prostatic hyperplasia which may require surgery.
Known pheochromocytoma, history of narrow angle glaucoma, Gilles de la Tourette syndrome, history of seizures, history of bariatric or abdominal obesity surgery (excluding liposuction).
Concomitant use of monoamine oxidase inhibitors or drugs that increase levels of serotonin in the brain.
Treated hypertension stabilized for less than 3 months.
Inability to perform regular physical activity.

Trial locations and contacts

1 site in 1 country.

United States1 site

Global Medical Services
North Chicago, Illinois, 60064

Other trials in United States

About this study

Official title: Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event

The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.

Read the detailed description

The study consisted of 4 periods: 1) a Screening Period of approximately 2 weeks; 2) a 6-week Lead-in Period, during which subjects received single-blind sibutramine and country-specific standard of care for weight management. Subjects who discontinued study drug treatment during the Lead-in Period were not randomized and did not participate in the double-blind Treatment Period or the Follow-up Period; 3) a double-blind Treatment Period in which subjects were randomized to 1 of the 2 treatment groups and were followed until the study ended; and 4) a double-blind Follow-up Period, during which randomized subjects who discontinued study drug were followed until the study ended. The Randomization Phase consisted of the double-blind Treatment Period and the double-blind Follow-up Period. Subjects received country-specific standard of care for weight management during the Randomization Phase.

An independent events adjudication committee evaluated all potential cardiovascular outcome events and confirmed the outcome events and time of onset to be included in the statistical analyses.

Conditions: Obesity
Being tested: Sibutramine hydrochloride, Placebo
Keywords: Obesity, Sibutramine
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sibutramine hydrochlorideDrug
Also called ABT-991, sibutramine, Meridia, Reductil
One 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
PlaceboDrug
1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)
Sibutramine hydrochlorideDrug
10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management

Study groups in NCT00234832
Study group	Role	What they receive
Sibutramine	Experimental	Subjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period Receives: Drug: Sibutramine hydrochloride
Placebo	Placebo comparator	Subjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period Receives: Drug: Placebo
Lead-in sibutramine	Experimental	All subjects received 10 mg sibutramine QD during a 6-week Lead-in Period Receives: Drug: Sibutramine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.
Measured: From randomization up to 6 years

Secondary outcomes (6)

Risk of Death From Any Cause (All-cause Mortality)
For each subject who died, the time to death was evaluated using time-to-event analysis.
Measured: From randomization up to 6 years
Risk of Experiencing a POE or a Revascularization Procedure
This outcome includes nonfatal MI, nonfatal stroke, resuscitated cardiac arrest, CV death (including events such as fatal MI and fatal stroke), and any of the following revascularization procedures: percutaneous transluminal coronary angioplasty, coronary artery bypass graft, coronary artery stent placement, cardiac transplant, peripheral vascular bypass or angioplasty, and carotid endarterectomy. For each subject, the POE or revascularization status (yes/no) and time to first occurrence of an event using time-to-event analysis were evaluated.
Measured: From randomization up to 6 years
Risk of Experiencing a Nonfatal MI Included in the POE
For each subject, the first occurrence of a nonfatal MI included in the POE was evaluated using time-to-event analysis.
Measured: From randomization up to 6 years
Risk of Experiencing a Nonfatal Stroke Included in the POE
For each subject, the time to first occurrence of a nonfatal stroke included in the POE was evaluated using time-to-event analysis.
Measured: From randomization up to 6 years
Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE
For each subject, the time to first occurrence of a resuscitated cardiac arrest included in the POE was evaluated using time-to-event analysis.
Measured: From randomization up to 6 years
Risk of Experiencing Cardiovascular Death Included in the POE
For each subject, the time to cardiovascular death included in the POE was evaluated using time-to-event analysis.
Measured: From randomization up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2003Nov 2009

First posted10 Oct 2005 (estimated)
Study startJan 2003
Primary completionMar 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
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: 10,777 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00234832
Sponsor's protocol ID: M01-392
Acronym: SCOUT
Status last verified: May 2010
First submitted: 13 Sep 2005
Last updated: 11 May 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Jorgensen ME, Torp-Pedersen C, Finer N, Caterson I, James WP, Legler UF, Andersson C. Association between serum bilirubin and cardiovascular disease in an overweight high risk population from the SCOUT trial. Nutr Metab Cardiovasc Dis. 2014 Jun;24(6):656-62. doi: 10.1016/j.numecd.2013.12.009. Epub 2014 Jan 18.
PubMed 24534073
Seimon RV, Espinoza D, Ivers L, Gebski V, Finer N, Legler UF, Sharma AM, James WP, Coutinho W, Caterson ID. Changes in body weight and blood pressure: paradoxical outcome events in overweight and obese subjects with cardiovascular disease. Int J Obes (Lond). 2014 Sep;38(9):1165-71. doi: 10.1038/ijo.2014.2. Epub 2014 Jan 10.
PubMed 24406481
James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Torp-Pedersen C, Sharma AM, Shepherd GM, Rode RA, Renz CL; SCOUT Investigators. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010 Sep 2;363(10):905-17. doi: 10.1056/NEJMoa1003114.
PubMed 20818901
Weeke P, Andersson C, Fosbol EL, Brendorp B, Kober L, Sharma AM, Finer N, James PT, Caterson ID, Rode RA, Torp-Pedersen C. The weight lowering effect of sibutramine and its impact on serum lipids in cardiovascular high risk patients with and without type 2 diabetes mellitus - an analysis from the SCOUT lead-in period. BMC Endocr Disord. 2010 Feb 26;10:3. doi: 10.1186/1472-6823-10-3.
PubMed 20184783
Andersson C, Weeke P, Brendorp B, Kober L, Fosbol EL, Sharma AM, Finer N, Caterson ID, Rode RA, James PT, Torp-Pedersen C. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial. Nutr Metab (Lond). 2009 Oct 14;6:42. doi: 10.1186/1743-7075-6-42.
PubMed 19828038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sibutramine Cardiovascular Morbidity/Mortality Outcomes Study in Overweight or Obese Subjects at Risk of a Cardiovascular Event
ClinicalTrials.gov ID: NCT00234832
Acronym / sponsor ID: SCOUT / M01-392
Conditions: Obesity
Keywords: Obesity, Sibutramine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 10,777 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Study start: Jan 2003
Primary completion: Mar 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 10 Oct 2005 (estimated)
Results: Posted 15 Apr 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of the study was to determine the long-term effect of sibutramine treatment on cardiovascular outcomes in overweight and obese patients at risk of a cardiovascular event.

Detailed description

An independent events adjudication committee evaluated all potential cardiovascular outcome events and confirmed the outcome events and time of onset to be included in the statistical analyses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Sibutramine	Experimental	Drug: Sibutramine hydrochlorideSubjects were randomized to receive sibutramine 10 mg once daily (QD) during the Treatment Period after a 6-week Lead-in Period
Placebo	Placebo comparator	Drug: PlaceboSubjects were randomized to receive placebo QD during the Treatment Period after a 6-week Lead-in Period
Lead-in sibutramine	Experimental	Drug: Sibutramine hydrochlorideAll subjects received 10 mg sibutramine QD during a 6-week Lead-in Period

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject's body mass index (BMI) was >= 27 kg/m(2) and <= 45 kg/m(2) or their BMI was >= 25 kg/m(2) and < 27 kg/m(2) with waist circumference of >= 102 cm in males or >= 88 cm in females.
Medical history positive for:

Key exclusion criteria (18 listed)

History of recent myocardial infarction.
Heart failure symptoms greater than New York Heart Association Functional Class II.
Hemodynamically significant valvular or left ventricular (LV) tract obstruction.
Subjects without a pacemaker and with any of the following:
Mean sitting systolic blood pressure (SBP) > 160 mmHg. Mean sitting diastolic blood pressure (DBP) > 100 mmHg. Mean sitting heart rate (HR) > 100 bpm.

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
Sibutramine hydrochlorideAlso: ABT-991, sibutramine, Meridia, ReductilOne 10 mg tablet QD plus country-specific standard care for weight management. (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)	Drug	Sibutramine
Placebo1 tablet QD plus country-specific standard care for weight management (During the Treatment Period, the dose could have been titrated up to 15 mg at the investigator's discretion.)	Drug	Placebo
Sibutramine hydrochloride10 mg tablet QD during the 6-week Lead-in Period plus country-specific standard care for weight management	Drug	Lead-in sibutramine

Primary outcome

Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)
Time frame: From randomization up to 6 years
For each subject, POE status (with/without an event) and time to first occurrence of a POE using time-to-event analysis were evaluated. All POE confirmed by an independent adjudication committee were included in the analysis.

6 secondary outcomes

Risk of Death From Any Cause (All-cause Mortality)
Time frame: From randomization up to 6 years
Risk of Experiencing a POE or a Revascularization Procedure
Time frame: From randomization up to 6 years
Risk of Experiencing a Nonfatal MI Included in the POE
Time frame: From randomization up to 6 years
Risk of Experiencing a Nonfatal Stroke Included in the POE
Time frame: From randomization up to 6 years
Risk of Experiencing a Resuscitated Cardiac Arrest Included in the POE
Time frame: From randomization up to 6 years
Risk of Experiencing Cardiovascular Death Included in the POE
Time frame: From randomization up to 6 years

Results and safety

Results posted to the registry on 15 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Randomized Sibutramine	4,906	3,890
Randomized Placebo	4,898	3,902

Primary outcome: Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death)

Time frame: From randomization up to 6 years. Number. Unit: Participants

Measure	Randomized Sibutramine n = 4906	Randomized Placebo n = 4898	DM Only Randomized to Sibutramine n = 1207	DM Only Randomized to Placebo n = 1178	CV Only Randomized to Sibutramine n = 759	CV Only Randomized to Placebo n = 793	CV + DM Randomized to Sibutramine n = 2906	CV + DM Randomized to Placebo n = 2901
Intent-to-treat population	561	490	79	77	77	66	403	346

Randomized Sibutramine vs Randomized Placebo: Cox Proportional Hazard: 1.162 (95% CI 1.029 to 1.311), p = 0.015, Log Rank
DM Only Randomized to Sibutramine vs DM Only Randomized to Placebo: Cox Proportional Hazard: 1.010 (95% CI 0.738 to 1.384), p = 0.948, Log Rank
CV Only Randomized to Sibutramine vs CV Only Randomized to Placebo: Cox Proportional Hazard: 1.276 (95% CI 0.916 to 1.776), p = 0.149, Log Rank

Population analysed: Analysis based on intent-to-treat (ITT) population, which consists of all randomized subjects dispensed randomized study drug and grouped according to the intervention to which they were randomized. Subjects were also categorized into 1 of 3 prespecified CV risk groups: diabetes mellitus (DM) only, CV only, and CV + DM.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent serious adverse events (SAE) were defined as those that began on or after the first dose of randomized study drug (sibutramine or placebo) during the Randomization Phase through 30 days after the last dose.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lead-in Period Sibutramine	425 of 10,744 (4%)	0 of 0	Not reported
Randomized Sibutramine	2,063 of 4,904 (42.1%)	0 of 0	Not reported
Randomized Placebo	1,977 of 4,881 (40.5%)	0 of 0	Not reported

Limitations and caveats (from the sponsor): Most subjects not indicated for sibutramine (sbt) due to CV disease. Long-term sbt use (6 yrs) regardless of weight loss, is inconsistent with label (limits use to 1-2 yrs \& 5% weight loss). Trial lacked true placebo; all received Lead-in Period sbt.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24534073Jorgensen ME, Torp-Pedersen C, Finer N, Caterson I, James WP, Legler UF, Andersson C. Association between serum bilirubin and cardiovascular disease in an overweight high risk population from the SCOUT trial. Nutr Metab Cardiovasc Dis. 2014 Jun;24(6):656-62. doi: 10.1016/j.numecd.2013.12.009. Epub 2014 Jan 18.
Derived from this study: PubMed 24406481Seimon RV, Espinoza D, Ivers L, Gebski V, Finer N, Legler UF, Sharma AM, James WP, Coutinho W, Caterson ID. Changes in body weight and blood pressure: paradoxical outcome events in overweight and obese subjects with cardiovascular disease. Int J Obes (Lond). 2014 Sep;38(9):1165-71. doi: 10.1038/ijo.2014.2. Epub 2014 Jan 10.
Derived from this study: PubMed 20818901James WP, Caterson ID, Coutinho W, Finer N, Van Gaal LF, Maggioni AP, Torp-Pedersen C, Sharma AM, Shepherd GM, Rode RA, Renz CL; SCOUT Investigators. Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects. N Engl J Med. 2010 Sep 2;363(10):905-17. doi: 10.1056/NEJMoa1003114.
Derived from this study: PubMed 20184783Weeke P, Andersson C, Fosbol EL, Brendorp B, Kober L, Sharma AM, Finer N, James PT, Caterson ID, Rode RA, Torp-Pedersen C. The weight lowering effect of sibutramine and its impact on serum lipids in cardiovascular high risk patients with and without type 2 diabetes mellitus - an analysis from the SCOUT lead-in period. BMC Endocr Disord. 2010 Feb 26;10:3. doi: 10.1186/1472-6823-10-3.
Derived from this study: PubMed 19828038Andersson C, Weeke P, Brendorp B, Kober L, Fosbol EL, Sharma AM, Finer N, Caterson ID, Rode RA, James PT, Torp-Pedersen C. Differential changes in serum uric acid concentrations in sibutramine promoted weight loss in diabetes: results from four weeks of the lead-in period of the SCOUT trial. Nutr Metab (Lond). 2009 Oct 14;6:42. doi: 10.1186/1743-7075-6-42.

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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.

Cheryl Renz, MD study director

Abbott

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 Sibutramine hydrochloride in people with Obesity, run by Abbott at 1 site in United States.

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 18 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 11 May 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 United States. 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?

Yes. Results are posted in the registry (first posted 15 Apr 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Risk of Experiencing a Primary Outcome Event (POE) (i.e., Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, Resuscitated Cardiac Arrest, Cardiovascular [CV] Death) (time frame: From randomization up to 6 years). 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 NCT00234832, which also lists 5 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 11 May 2010.