Trial Outcomes & Findings for Treatment of Resistant Hypertension by Prevention of T-Cell Co-Stimulation (NCT NCT02232880)

Results Overview

Ambulatory blood pressure monitoring will be used at the end of the 4 weeks standardized treatment and at the end of 6 months randomized treatment with abatacept or placebo. The change in systolic blood pressure from these 2 recordings will be the primary endpoint.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2017-02-07

Participant Flow

One participant was consented. The study terminated before the participant was randomized. No participants received treatment.

Participant milestones

Participant milestones
Measure	Consented Patients
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Consented Patients
Overall Study study stopped prior to randomization	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Consented Patients n=1 Participants No patients received treatment prior to study termination
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	1 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: No patients received treatment prior to study termination

Ambulatory blood pressure monitoring will be used at the end of the 4 weeks standardized treatment and at the end of 6 months randomized treatment with abatacept or placebo. The change in systolic blood pressure from these 2 recordings will be the primary endpoint.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No patients received treatment prior to study termination.

Changes in the rate of change of blood pressure estimated by automated in office cuff measurements and ambulatory blood pressure at 12 weeks after randomization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No patients received treatment prior to study termination

change in brachial artery reactivity measured at randomization and after 24 weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No patients received treatment prior to study termination

changes in plasma and T cell markers of activation and T cell cytokine production from randomization to end of 24 weeks of treatment

Outcome measures

Outcome data not reported

Adverse Events

Consented Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Harrison

Vanderbilt University

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place