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Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Abatacept (Drug); Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
David G Harrison, MD, Principal Investigator, Affiliation: Vanderbilt University


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 be studied in people with high blood pressure that is not well controlled on three or more blood pressure medications, the condition also known as resistant hypertension. We expect to show that adding abatacept therapy to standardized treatment of resistant hypertension will result in a greater decrease in blood pressure at 24 weeks compared to treatment with placebo and conventional blood pressure treatment.

Clinical Details

Official title: Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation

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

Primary outcome: Change in systolic blood pressure from randomization to end of treatment

Secondary outcome:

change in blood pressure

change in brachial artery reactivity

change in inflammatory markers


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- 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 Criteria:

- 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


- 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.

Locations and Contacts

Vanderbilt University Medical Center, Nashville, Tennessee 37232-6602, United States
Additional Information

Starting date: August 2014
Last updated: June 1, 2015

Page last updated: August 23, 2015

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