HypertensionPhase 2NCT01602367
Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients
A Phase 2 study testing BMS-823778 in people with Hypertension, run by Bristol-Myers Squibb at 35 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- BMS-823778
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 35 sitesin 5 countries
- Study dates
- Jul 2012to Nov 2012
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic
- Mean 24-hour diastolic blood pressure ≥85 mmHg
- Body mass index (BMI) ≥27 kg/m2
- If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks
Who cannot join
- History of Cushing's disease or syndrome, or Addison's disease
- Glycosylated hemoglobin (HbA1c) ≥10%
- Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months
- History of impaired renal or hepatic function
- BMI ≥50 kg/m2
- Any injectable antihyperglycemic agent (such as insulin) within 16 weeks
Show all 10Show fewer
- Currently receiving more than one class of antihypertensive agents within 4 weeks
- Daily use of nonsteroidal anti-inflammatory agents within 1 week
- Use of androgen medications, including topical preparations, within 6 weeks
- Diagnosis or history of breast cancer
Trial locations and contacts
35 sites in 5 countries.
35 sites in 5 countries
United States22 sites
Local Institution
Atlanta, Georgia, 30303
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
Metrolina Internal Medicine
Charlotte, North Carolina, 28204
Sterling Research Grp, Ltd.
Cincinnati, Ohio, 45246
Local Institution
Coral Gables, Florida, 33134
Anderson And Collins Clinical Research, Inc.
Edison, New Jersey, 08817
Pharmquest, Llc
Greensboro, North Carolina, 27408
Local Institution
Greenville, South Carolina, 29615
Nea Baptist Clinic
Jonesboro, Arkansas, 72401
Local Institution
Layton, Utah, 84041
Local Institution
Los Angeles, California, 90057
Manassas Clinical Research Center
Manassas, Virginia, 20110
Local Institution
New Orleans, Louisiana, 70115
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, 23502
Desert Medical Group Inc.
Palm Springs, California, 92262
National Clinical Research - Richmond, Inc.
Richmond, Virginia, 23294
Pmg Research Of Salisbury
Salisbury, North Carolina, 28144
Local Institution
Shelby, North Carolina, 28150
Local Institution
Shelby, North Carolina, 28152
Syracuse Preventive Cardiology
Syracuse, New York, 13202-3108
Premier Research
Trenton, New Jersey, 08611
Local Institution
Winston-Salem, North Carolina, 27103
Colombia5 sites
Local Institution
Barranquilla
Local Institution
Bucaramanga
Local Institution
Cartagena
Local Institution
Manizales
Local Institution
Medellín
Hungary5 sites
Local Institution
Balatonfüred, H-8230
Local Institution
Budapest, 1125
Local Institution
Budapest, 1133
Local Institution
Budapest, 1134
Local Institution
Debrecen, 4026
Sweden2 sites
Local Institution
Ödeshög, 599 31
Local Institution
Stockholm, 141 86
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2B Trial to Evaluate the Safety and Efficacy of BMS-823778 in Overweight and Obese Subjects With Inadequately Controlled Hypertension
The purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.
- Conditions
- Hypertension
- Being tested
- BMS-823778, Placebo matching with BMS-823778
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-823778Drug
Capsules, Oral, 2 mg, Once daily, 12 weeks
BMS-823778Drug
Capsules, Oral, 6 mg, Once daily, 12 weeks
BMS-823778Drug
Capsules, Oral, 15 mg, Once daily, 12 weeks
Placebo matching with BMS-823778Drug
Capsules, Oral, 0 mg, Once daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: BMS-823778 (2mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| Arm2: BMS-823778 (6mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| Arm 3: BMS-823778 (15mg) | Experimental | Not described Receives: Drug: BMS-823778 |
| Arm4: Placebo | Experimental | Not described Receives: Drug: Placebo matching with BMS-823778 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment
Measured: At Day -7 (baseline) and Week 12
Secondary outcomes (7)
Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)
Measured: At Day -7 (baseline) and Week 12
Change in 24-hour ambulatory diastolic blood pressure (DBP)
Measured: At Day -7 (baseline) and Week 12
Change in 24-hour ambulatory SBP
Measured: At Day -7 (baseline) and Week 12
Change in ambulatory daytime and nighttime DBP
Measured: At Day -7 (baseline) and Week 12
Change in ambulatory daytime and nighttime SBP
Measured: At Day -7 (baseline) and Week 12
Change in seated DBP
Measured: At Day -7 (baseline) and Week 12
Change in seated SBP
Measured: At Day -7 (baseline) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startJul 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602367
- Sponsor's protocol ID
- MB121-008
- Other IDs
- 2012-000509-54
- Status last verified
- Sep 2015
- First submitted
- 17 May 2012
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2B Trial to Evaluate the Safety and Efficacy of BMS-823778 in Overweight and Obese Subjects With Inadequately Controlled Hypertension
- ClinicalTrials.gov ID
- NCT01602367
- Acronym / sponsor ID
- MB121-008
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 21 May 2012 (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 purpose of this study is to determine whether BMS-823778 is safe and effective in the treatment of hypertension in overweight and obese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: BMS-823778 (2mg) | Experimental | Drug: BMS-823778 |
| Arm2: BMS-823778 (6mg) | Experimental | Drug: BMS-823778 |
| Arm 3: BMS-823778 (15mg) | Experimental | Drug: BMS-823778 |
| Arm4: Placebo | Experimental | Drug: Placebo matching with BMS-823778 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Qualifying seated blood pressure between ≥90 and ≤105 mmHg diastolic AND ≤155 mmHg systolic
- Mean 24-hour diastolic blood pressure ≥85 mmHg
- Body mass index (BMI) ≥27 kg/m2
- If receiving an oral anti-hyperglycemic medication or a cholesterol lowering medication, receiving a stable dose for at least 6 weeks
Key exclusion criteria (10 listed)
- History of Cushing's disease or syndrome, or Addison's disease
- Glycosylated hemoglobin (HbA1c) ≥10%
- Cerebrovascular insult, unstable angina, or myocardial infarction (MI) within 6 months
- History of impaired renal or hepatic function
- BMI ≥50 kg/m2
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 |
|---|---|---|
| BMS-823778Capsules, Oral, 2 mg, Once daily, 12 weeks | Drug | Arm 1: BMS-823778 (2mg) |
| BMS-823778Capsules, Oral, 6 mg, Once daily, 12 weeks | Drug | Arm2: BMS-823778 (6mg) |
| BMS-823778Capsules, Oral, 15 mg, Once daily, 12 weeks | Drug | Arm 3: BMS-823778 (15mg) |
| Placebo matching with BMS-823778Capsules, Oral, 0 mg, Once daily, 12 weeks | Drug | Arm4: Placebo |
Primary outcome
The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment
Time frame: At Day -7 (baseline) and Week 12
7 secondary outcomes
Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)
Time frame: At Day -7 (baseline) and Week 12
Change in 24-hour ambulatory diastolic blood pressure (DBP)
Time frame: At Day -7 (baseline) and Week 12
Change in 24-hour ambulatory SBP
Time frame: At Day -7 (baseline) and Week 12
Change in ambulatory daytime and nighttime DBP
Time frame: At Day -7 (baseline) and Week 12
Change in ambulatory daytime and nighttime SBP
Time frame: At Day -7 (baseline) and Week 12
Change in seated DBP
Time frame: At Day -7 (baseline) and Week 12
Change in seated SBP
Time frame: At Day -7 (baseline) and Week 12
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
35 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-823778 in people with Hypertension, run by Bristol-Myers Squibb at 35 sites in 5 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 4 inclusion and 10 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 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Colombia, Hungary, Sweden, Puerto Rico. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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. 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?
The dose-dependent trend among doses of BMS-823778 and placebo by assessing the change from baseline in 24-hour ambulatory diastolic blood pressure following 12 weeks of double-blind treatment (time frame: At Day -7 (baseline) and Week 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 12 Oct 2015.