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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01602367
• Collaborator: (none)
• Enrollment: 7
• Locations: 35
• Arms: 4
• Duration (Months): 4
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: BMS-823778; Drug: BMS-823778; Drug: BMS-823778; Drug: Placebo matching with BMS-823778	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Jul 1, 2012
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1: BMS-823778 (2mg)	Drug: BMS-823778; Capsules, Oral, 2 mg, Once daily, 12 weeks
Experimental: Arm2: BMS-823778 (6mg)	Drug: BMS-823778; Capsules, Oral, 6 mg, Once daily, 12 weeks
Experimental: Arm 3: BMS-823778 (15mg)	Drug: BMS-823778; Capsules, Oral, 15 mg, Once daily, 12 weeks
Experimental: Arm4: Placebo	Drug: Placebo matching with BMS-823778; Capsules, Oral, 0 mg, Once daily, 12 weeks

Outcome Measures

Primary Outcome Measures

1. 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 [At Day -7 (baseline) and Week 12]

Secondary Outcome Measures

1. Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend) [At Day -7 (baseline) and Week 12]

2. Change in 24-hour ambulatory diastolic blood pressure (DBP) [At Day -7 (baseline) and Week 12]

3. Change in 24-hour ambulatory SBP [At Day -7 (baseline) and Week 12]

4. Change in ambulatory daytime and nighttime DBP [At Day -7 (baseline) and Week 12]

5. Change in ambulatory daytime and nighttime SBP [At Day -7 (baseline) and Week 12]

6. Change in seated DBP [At Day -7 (baseline) and Week 12]

7. Change in seated SBP [At Day -7 (baseline) and Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nea Baptist Clinic	Jonesboro	Arkansas	United States	72401
2	Local Institution	Los Angeles	California	United States	90057
3	Desert Medical Group Inc.	Palm Springs	California	United States	92262
4	Local Institution	Coral Gables	Florida	United States	33134
5	Local Institution	Atlanta	Georgia	United States	30303
6	Pennington Biomedical Research Center	Baton Rouge	Louisiana	United States	70808-4124
7	Local Institution	New Orleans	Louisiana	United States	70115
8	Anderson And Collins Clinical Research, Inc.	Edison	New Jersey	United States	08817
9	Premier Research	Trenton	New Jersey	United States	08611
10	Syracuse Preventive Cardiology	Syracuse	New York	United States	13202-3108
11	Metrolina Internal Medicine	Charlotte	North Carolina	United States	28204
12	Pharmquest, Llc	Greensboro	North Carolina	United States	27408
13	Pmg Research Of Salisbury	Salisbury	North Carolina	United States	28144
14	Local Institution	Shelby	North Carolina	United States	28150
15	Local Institution	Shelby	North Carolina	United States	28152
16	Local Institution	Winston-salem	North Carolina	United States	27103
17	Sterling Research Grp, Ltd.	Cincinnati	Ohio	United States	45246
18	Local Institution	Greenville	South Carolina	United States	29615
19	Local Institution	Layton	Utah	United States	84041
20	Manassas Clinical Research Center	Manassas	Virginia	United States	20110
21	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia	United States	23502
22	National Clinical Research - Richmond, Inc.	Richmond	Virginia	United States	23294
23	Local Institution	Barranquilla		Colombia
24	Local Institution	Bucaramanga		Colombia
25	Local Institution	Cartagena		Colombia
26	Local Institution	Manizales		Colombia
27	Local Institution	Medellin		Colombia
28	Local Institution	Balatonfured		Hungary	H-8230
29	Local Institution	Budapest		Hungary	1125
30	Local Institution	Budapest		Hungary	1133
31	Local Institution	Budapest		Hungary	1134
32	Local Institution	Debrecen		Hungary	4026
33	Local Institution	Ponce		Puerto Rico	00717
34	Local Institution	Odeshog		Sweden	599 31
35	Local Institution	Stockholm		Sweden	141 86

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS clinical trial educational resource

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01602367
• Other Study ID Numbers: MB121-008; 2012-000509-54
• First Posted: May 21, 2012
• Last Update Posted: Oct 12, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Hypertension; Overweight

Study Results

No Results Posted as of Oct 12, 2015