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Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients

Primary Purpose

Hypertension

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-823778
BMS-823778
BMS-823778
Placebo matching with BMS-823778
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nea Baptist Clinic
  • Local Institution
  • Desert Medical Group Inc.
  • Local Institution
  • Local Institution
  • Pennington Biomedical Research Center
  • Local Institution
  • Anderson And Collins Clinical Research, Inc.
  • Premier Research
  • Syracuse Preventive Cardiology
  • Metrolina Internal Medicine
  • Pharmquest, Llc
  • Pmg Research Of Salisbury
  • Local Institution
  • Local Institution
  • Local Institution
  • Sterling Research Grp, Ltd.
  • Local Institution
  • Local Institution
  • Manassas Clinical Research Center
  • National Clinical Research - Norfolk, Inc.
  • National Clinical Research - Richmond, Inc.
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: BMS-823778 (2mg)

Arm2: BMS-823778 (6mg)

Arm 3: BMS-823778 (15mg)

Arm4: Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)
Change in 24-hour ambulatory diastolic blood pressure (DBP)
Change in 24-hour ambulatory SBP
Change in ambulatory daytime and nighttime DBP
Change in ambulatory daytime and nighttime SBP
Change in seated DBP
Change in seated SBP

Full Information

First Posted
May 17, 2012
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01602367
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: BMS-823778 (2mg)
Arm Type
Experimental
Arm Title
Arm2: BMS-823778 (6mg)
Arm Type
Experimental
Arm Title
Arm 3: BMS-823778 (15mg)
Arm Type
Experimental
Arm Title
Arm4: Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 2 mg, Once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 6 mg, Once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-823778
Intervention Description
Capsules, Oral, 15 mg, Once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching with BMS-823778
Intervention Description
Capsules, Oral, 0 mg, Once daily, 12 weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)
Time Frame
At Day -7 (baseline) and Week 12
Title
Change in 24-hour ambulatory diastolic blood pressure (DBP)
Time Frame
At Day -7 (baseline) and Week 12
Title
Change in 24-hour ambulatory SBP
Time Frame
At Day -7 (baseline) and Week 12
Title
Change in ambulatory daytime and nighttime DBP
Time Frame
At Day -7 (baseline) and Week 12
Title
Change in ambulatory daytime and nighttime SBP
Time Frame
At Day -7 (baseline) and Week 12
Title
Change in seated DBP
Time Frame
At Day -7 (baseline) and Week 12
Title
Change in seated SBP
Time Frame
At Day -7 (baseline) and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Nea Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Desert Medical Group Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Local Institution
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Local Institution
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808-4124
Country
United States
Facility Name
Local Institution
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Anderson And Collins Clinical Research, Inc.
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
Facility Name
Premier Research
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08611
Country
United States
Facility Name
Syracuse Preventive Cardiology
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202-3108
Country
United States
Facility Name
Metrolina Internal Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Pharmquest, Llc
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Pmg Research Of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Local Institution
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Local Institution
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28152
Country
United States
Facility Name
Local Institution
City
Winston-salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Sterling Research Grp, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Local Institution
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Local Institution
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
National Clinical Research - Norfolk, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
National Clinical Research - Richmond, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Local Institution
City
Barranquilla
Country
Colombia
Facility Name
Local Institution
City
Bucaramanga
Country
Colombia
Facility Name
Local Institution
City
Cartagena
Country
Colombia
Facility Name
Local Institution
City
Manizales
Country
Colombia
Facility Name
Local Institution
City
Medellin
Country
Colombia
Facility Name
Local Institution
City
Balatonfured
ZIP/Postal Code
H-8230
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4026
Country
Hungary
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Local Institution
City
Odeshog
ZIP/Postal Code
599 31
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

Safety and Efficacy Study of BMS-823778 to Treat Uncontrolled High Blood Pressure in Overweight and Obese Patients

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