ObesityPhase 3HOSNCT00679653
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
A Phase 3 study testing sibutramine, verapamil/trandolapril and metoprolol/HCT in people with Obesity and Hypertension, run by Abbott.
Trial summary
To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- sibutramine, verapamil/trandolapril and metoprolol/HCT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- No sites listed yet
- Study dates
- Feb 2002to Dec 2003
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated essential hypertension.
- Obesity: BMI 27-35 kg/m2
Who cannot join
- Secondary hypertension.
- Stage 3 hypertension.
- Secondary obesity; BMI > 35kg/m2.
- CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis.
- Kidney failure.
- Liver failure.
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- Hyperthyroidism.
- Unstable DM.
- Carcinoma.
- Severe chronic infectious disease.
- Alcohol or drug abuse.
- Pregnancy.
- Epilepsy.
- Psychosis or treatment with antidepressants or major tranquilizers
About this study
To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.
- Conditions
- Obesity, Hypertension
- Being tested
- sibutramine, verapamil/trandolapril, metoprolol/HCT, felodipine/ramipril
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sibutramineDrug
Also called ABT-991, Meridia, Reductil
8-wks, sibutramine, 10 mg, capsules, once daily
sibutramineDrug
Also called ABT-991, Meridia, Reductil
8-wks, sibutramine, 15 mg, capsules, once daily
verapamil/trandolaprilDrug
2 wk Run-in phase, antihypertensive therapy only
metoprolol/HCTDrug
2 wk Run-in phase, antihypertensive therapy only
felodipine/ramiprilDrug
2 wk Run-in phase, antihypertensive therapy only
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | verapamil/trandolapril Receives: Drug: sibutramine; Drug: verapamil/trandolapril |
| 2 | Active comparator | metoprolol/HCT Receives: Drug: sibutramine; Drug: metoprolol/HCT |
| 3 | Active comparator | felodipine/ramipril Receives: Drug: sibutramine; Drug: felodipine/ramipril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure
Measured: Duration of Study
Diastolic Blood Pressure
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startFeb 2002
- Primary completionDec 2003
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.
- 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
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679653
- Sponsor's protocol ID
- KD200010
- Acronym
- HOS
- Status last verified
- May 2008
- First submitted
- 26 Mar 2008
- Last updated
- 19 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
- ClinicalTrials.gov ID
- NCT00679653
- Acronym / sponsor ID
- HOS / KD200010
- Conditions
- Obesity, Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- Primary completion
- Dec 2003 (actual)
- First posted
- 19 May 2008 (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.
To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sibutramine, Drug: verapamil/trandolaprilverapamil/trandolapril |
| 2 | Active comparator | Drug: sibutramine, Drug: metoprolol/HCTmetoprolol/HCT |
| 3 | Active comparator | Drug: sibutramine, Drug: felodipine/ramiprilfelodipine/ramipril |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treated essential hypertension.
- Obesity: BMI 27-35 kg/m2
Key exclusion criteria (14 listed)
- Secondary hypertension.
- Stage 3 hypertension.
- Secondary obesity; BMI > 35kg/m2.
- CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis.
- Kidney failure.
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 |
|---|---|---|
| sibutramineAlso: ABT-991, Meridia, Reductil8-wks, sibutramine, 10 mg, capsules, once daily | Drug | 1, 2, 3 |
| sibutramineAlso: ABT-991, Meridia, Reductil8-wks, sibutramine, 15 mg, capsules, once daily | Drug | 1, 2, 3 |
| verapamil/trandolapril2 wk Run-in phase, antihypertensive therapy only | Drug | 1 |
| metoprolol/HCT2 wk Run-in phase, antihypertensive therapy only | Drug | 2 |
| felodipine/ramipril2 wk Run-in phase, antihypertensive therapy only | Drug | 3 |
Primary outcome
Systolic Blood Pressure
Time frame: Duration of Study
Diastolic Blood Pressure
Time frame: Duration of Study
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 19 May 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sibutramine, verapamil/trandolapril and metoprolol/HCT in people with Obesity and Hypertension, run by Abbott.
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 2 inclusion and 14 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 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.
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 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 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?
Systolic Blood Pressure (time frame: Duration of Study). 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 19 May 2008.