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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602367
• Other study ID #: MB121-008
• Secondary ID: 2012-000509-54
• Status: Terminated
• Phase: Phase 2
• First received: May 17, 2012
• Last updated: September 23, 2015
• Start date: July 2012
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationMexico: Ministry of HealthColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaSweden: Medical Products AgencyHungary: National Institute of PharmacyEuropean Union: European Medicines Agency
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• BMS-823778
Capsules, Oral, 2 mg, Once daily, 12 weeks
• BMS-823778
Capsules, Oral, 6 mg, Once daily, 12 weeks
• BMS-823778
Capsules, Oral, 15 mg, Once daily, 12 weeks
• Placebo matching with BMS-823778
Capsules, Oral, 0 mg, Once daily, 12 weeks

Locations

Country	Name	City	State
Colombia	Local Institution	Barranquilla
Colombia	Local Institution	Bucaramanga
Colombia	Local Institution	Cartagena
Colombia	Local Institution	Manizales
Colombia	Local Institution	Medellin
Hungary	Local Institution	Balatonfured
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Puerto Rico	Local Institution	Ponce
Sweden	Local Institution	Odeshog
Sweden	Local Institution	Stockholm
United States	Local Institution	Atlanta	Georgia
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Metrolina Internal Medicine	Charlotte	North Carolina
United States	Sterling Research Grp, Ltd.	Cincinnati	Ohio
United States	Local Institution	Coral Gables	Florida
United States	Anderson And Collins Clinical Research, Inc.	Edison	New Jersey
United States	Pharmquest, Llc	Greensboro	North Carolina
United States	Local Institution	Greenville	South Carolina
United States	Nea Baptist Clinic	Jonesboro	Arkansas
United States	Local Institution	Layton	Utah
United States	Local Institution	Los Angeles	California
United States	Manassas Clinical Research Center	Manassas	Virginia
United States	Local Institution	New Orleans	Louisiana
United States	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia
United States	Desert Medical Group Inc.	Palm Springs	California
United States	National Clinical Research - Richmond, Inc.	Richmond	Virginia
United States	Pmg Research Of Salisbury	Salisbury	North Carolina
United States	Local Institution	Shelby	North Carolina
United States	Local Institution	Shelby	North Carolina
United States	Syracuse Preventive Cardiology	Syracuse	New York
United States	Premier Research	Trenton	New Jersey
United States	Local Institution	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Colombia,  Hungary,  Puerto Rico,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in 24-hour ambulatory systolic blood pressure (SBP)(evaluation of the dose-dependent trend)		At Day -7 (baseline) and Week 12	No
Secondary	Change in 24-hour ambulatory diastolic blood pressure (DBP)		At Day -7 (baseline) and Week 12	No
Secondary	Change in 24-hour ambulatory SBP		At Day -7 (baseline) and Week 12	No
Secondary	Change in ambulatory daytime and nighttime DBP		At Day -7 (baseline) and Week 12	No
Secondary	Change in ambulatory daytime and nighttime SBP		At Day -7 (baseline) and Week 12	No
Secondary	Change in seated DBP		At Day -7 (baseline) and Week 12	No
Secondary	Change in seated SBP		At Day -7 (baseline) and Week 12	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form