Status:
TERMINATED
Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test whether abatacept, a drug approved by the Food and Drug Administration to treat rheumatoid arthritis, may help blood pressure medications to work better. This will...
Eligibility Criteria
Inclusion
- Men and women 18 to 65 years of age with hypertension, treated with three or more anti-hypertensive drugs, one being a diuretic, and
- having a systolic blood pressure \>150 mmHg in the clinic and daytime average \>150 mmHg on ambulatory blood pressure monitoring
Exclusion
- Medical history of secondary cause of hypertension, severe obesity (BMI \>35), severe psychiatric disorders, cancer in the last 5 years other than nonmelanoma skin cell cancers, herpes zoster or cytomegalovirus that resolved less than 2 months before
- Inability to return for abatacept treatment and follow-up for 24 weeks.
- Inability to understand or complete study-related assessments.
- Current abuse of drugs or alcohol.
- Receipt of any live vaccines within 3 months of the anticipated first dose of study medication.
- Evidence of active or latent bacterial or viral infections at the time of potential enrollment, including human immunodeficiency virus (HIV)
- Risk for tuberculosis
- Abnormal laboratory values including positive hepatitis B surface antigen, hemoglobin \< 8.5 g/dL, white blood cell count \< 3000/mm3, platelets \< 100,000/mm3, creatinine \> 2.5 times the upper limit of normal (ULN), alanine aminotransferase or aspartate aminotransferase \> 2 times the ULN.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT02232880
Start Date
August 1 2014
End Date
June 1 2015
Last Update
February 7 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-6602