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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01602367

Enrollment

Registered

2012-05-21

Start date

2012-07-31

Completion date

2012-11-30

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGPlacebo matching with BMS-823778

Capsules, Oral, 0 mg, Once daily, 12 weeks

DRUGBMS-823778

Capsules, Oral, 2 mg, Once daily, 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change in 24-hour ambulatory diastolic blood pressure (DBP)	At Day -7 (baseline) and Week 12
Change in 24-hour ambulatory SBP	At Day -7 (baseline) and Week 12
Change in ambulatory daytime and nighttime DBP	At Day -7 (baseline) and Week 12
Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)	At Day -7 (baseline) and Week 12
Change in seated DBP	At Day -7 (baseline) and Week 12
Change in seated SBP	At Day -7 (baseline) and Week 12
Change in ambulatory daytime and nighttime SBP	At Day -7 (baseline) and Week 12

Countries

Colombia, Hungary, Puerto Rico, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026