Clinical trial NCT01602367: Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
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
timeFrame: At Day -7 (baseline) and Week 12
Secondary outcomes:
measure: Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)
timeFrame: At Day -7 (baseline) and Week 12
measure: Change in 24-hour ambulatory diastolic blood pressure (DBP)
timeFrame: At Day -7 (baseline) and Week 12
measure: Change in 24-hour ambulatory SBP
timeFrame: At Day -7 (baseline) and Week 12
measure: Change in ambulatory daytime and nighttime DBP
timeFrame: At Day -7 (baseline) and Week 12
measure: Change in ambulatory daytime and nighttime SBP
timeFrame: At Day -7 (baseline) and Week 12
measure: Change in seated DBP
timeFrame: At Day -7 (baseline) and Week 12
measure: Change in seated SBP
timeFrame: At Day -7 (baseline) and Week 12
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: Nea Baptist Clinic
state: Arkansas
city: Los Angeles
country: United States
facility: Local Institution
state: California
city: Palm Springs
country: United States
facility: Desert Medical Group Inc.
state: California
city: Coral Gables
country: United States
facility: Local Institution
state: Florida
city: Atlanta
country: United States
facility: Local Institution
state: Georgia
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: Local Institution
state: Louisiana
city: Edison
country: United States
facility: Anderson And Collins Clinical Research, Inc.
state: New Jersey
city: Trenton
country: United States
facility: Premier Research
state: New Jersey
city: Syracuse
country: United States
facility: Syracuse Preventive Cardiology
state: New York
city: Charlotte
country: United States
facility: Metrolina Internal Medicine
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest, Llc
state: North Carolina
city: Salisbury
country: United States
facility: Pmg Research Of Salisbury
state: North Carolina
city: Shelby
country: United States
facility: Local Institution
state: North Carolina
city: Shelby
country: United States
facility: Local Institution
state: North Carolina
city: Winston-salem
country: United States
facility: Local Institution
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Grp, Ltd.
state: Ohio
city: Greenville
country: United States
facility: Local Institution
state: South Carolina
city: Layton
country: United States
facility: Local Institution
state: Utah
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: National Clinical Research - Norfolk, Inc.
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research - Richmond, Inc.
state: Virginia
city: Barranquilla
country: Colombia
facility: Local Institution
city: Bucaramanga
country: Colombia
facility: Local Institution
city: Cartagena
country: Colombia
facility: Local Institution
city: Manizales
country: Colombia
facility: Local Institution
city: Medellin
country: Colombia
facility: Local Institution
city: Balatonfured
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Odeshog
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: