Trial Outcomes & Findings for Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension (NCT NCT00607477)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

21 days

Results posted on

2014-06-10

Participant milestones
Measure	Hydralazine 25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week	Minoxidil 2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
Overall Study STARTED	0	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

Baseline characteristics by cohort
Measure	Hydralazine 25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week	Minoxidil n=2 Participants 2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 participants n=7 Participants	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Age, Categorical >=65 years	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Female	—	1 participants n=7 Participants	1 participants n=5 Participants
Gender Male	—	1 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

Timeframe: 21 days

Population: No participants analyzed due to poor accrual and insufficient numbers of participants.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Hydralazine 25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week	Minoxidil n=2 participants at risk 2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
Gastrointestinal disorders diarrhea (grade 1)	— 0/0 • 21 days	50.0% 1/2 • Number of events 1 • 21 days

University of Chicago

Phone: 773-702-4400