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

NCT02232880 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-02-07

Study results available
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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 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.

Conditions

Interventions

DRUG

Abatacept

All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.

DRUG

Placebo

All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day \[Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day\], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.

Sponsors & Collaborators

Principal Investigators

  • David G Harrison, MD · Vanderbilt University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02232880 on ClinicalTrials.gov