Trial Outcomes & Findings for Conditioned Pharmacotherapeutic Effects in Hypertension (NCT NCT02056626)

NCT ID: NCT02056626

Last Updated: 2019-07-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 44 participants
• Primary outcome timeframe: day 0
• Results posted on: 2019-07-09

Participant Flow

Participant milestones

Measure	Partial Reinforcement partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol	Controlled Dosing, Daily controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol	Controlled Dosing, Every Other Day controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol	Standard Therapy standard therapy, 25 mg twice daily (15 days) carvedilol
Overall Study STARTED	13	13	4	14
Overall Study COMPLETED	10	12	4	14
Overall Study NOT COMPLETED	3	1	0	0

Reasons for withdrawal

Measure	Partial Reinforcement partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol	Controlled Dosing, Daily controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol	Controlled Dosing, Every Other Day controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol	Standard Therapy standard therapy, 25 mg twice daily (15 days) carvedilol
Overall Study patient did not follow directions	3	1	0	0

Baseline Characteristics

Conditioned Pharmacotherapeutic Effects in Hypertension

Baseline characteristics by cohort

Measure	Partial Reinforcement n=13 Participants partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol	Controlled Dosing, Daily n=13 Participants controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol	Controlled Dosing, Every Other Day n=4 Participants controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol	Standard Therapy n=14 Participants standard therapy, 25 mg twice daily (15 days) carvedilol	Total n=44 Participants Total of all reporting groups
Age, Continuous	44.62 years STANDARD_DEVIATION 10.23 • n=5 Participants	52.62 years STANDARD_DEVIATION 12.14 • n=7 Participants	58.00 years STANDARD_DEVIATION 6.88 • n=5 Participants	56.21 years STANDARD_DEVIATION 5.70 • n=4 Participants	51.89 years STANDARD_DEVIATION 10.45 • n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	21 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	23 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants	29 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	13 participants n=5 Participants	13 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants	44 participants n=21 Participants
Number of participants taking other antihypertensives	5 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Mean systolic blood pressure	151.59 mmHg STANDARD_DEVIATION 7.22 • n=5 Participants	152.64 mmHg STANDARD_DEVIATION 8.95 • n=7 Participants	155.42 mmHg STANDARD_DEVIATION 9.62 • n=5 Participants	151.88 mmHg STANDARD_DEVIATION 8.19 • n=4 Participants	152.34 mmHg STANDARD_DEVIATION 8.05 • n=21 Participants

PRIMARY outcome

Timeframe: day 0

Outcome measures

Measure	Partial Reinforcement n=10 Participants partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol	Controlled Dosing, Daily n=12 Participants controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol	Controlled Dosing, Every Other Day n=4 Participants controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol	Standard Therapy n=14 Participants standard therapy, 25 mg twice daily (15 days) carvedilol
Mean Systolic Blood Pressure	151.59 mmHg Standard Deviation 1.92	152.64 mmHg Standard Deviation 2.38	155.42 mmHg Standard Deviation 4.17	151.74 mmHg Standard Deviation 2.05

PRIMARY outcome

Timeframe: day 14

Outcome measures

Measure	Partial Reinforcement n=10 Participants partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol	Controlled Dosing, Daily n=12 Participants controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol	Controlled Dosing, Every Other Day n=4 Participants controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol	Standard Therapy n=14 Participants standard therapy, 25 mg twice daily (15 days) carvedilol
Mean Systolic Blood Pressure	133.64 mmHg Standard Deviation 2.58	132.92 mmHg Standard Deviation 3.20	133.12 mmHg Standard Deviation 3.20	135.00 mmHg Standard Deviation 2.21

PRIMARY outcome

Timeframe: day 30

Outcome measures

Measure	Partial Reinforcement n=10 Participants partial reinforcement, 6.25 mg twice daily, 25% of time (15 days) carvedilol	Controlled Dosing, Daily n=12 Participants controlled dosing schedule 6.25 mg twice daily (15 days) carvedilol	Controlled Dosing, Every Other Day n=4 Participants controlled dosing schedule 6.25 mg twice daily, every other day (15 days) carvedilol	Standard Therapy n=14 Participants standard therapy, 25 mg twice daily (15 days) carvedilol
Mean Systolic Blood Pressure	138.90 mmHg Standard Deviation 2.11	136.38 mmHg Standard Deviation 3.34	139.27 mmHg Standard Deviation 0.64	134.94 mmHg Standard Deviation 2.71

Adverse Events

Partial Reinforcement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controlled Dosing, Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controlled Dosing, Every Other Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Therapy

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

John Bisognano

University of Rochester

Phone: 585-341-7800

Email: john_bisognano @ urmc.rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place