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

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ClinicalTrials.gov Identifier: NCT00607477

Recruitment Status : Terminated (Study has been terminated due to poor accrual.)

First Posted : February 5, 2008

Results First Posted : February 16, 2011

Last Update Posted : June 10, 2014

Sponsor:

Information provided by (Responsible Party):

University of Chicago

Study Type	Interventional
Study Design	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Treatment Induced Hypertension
Interventions	Drug: Minoxidil Drug: Hydralazine
Enrollment	2

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Hydralazine	Minoxidil
Arm/Group Description	25 mg Hydralazine taken twice daily...	2.5 mg Minoxidil taken twice daily ...
Arm/Group Description	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	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
Period Title: Overall Study
Started	0	2
Completed	0	2
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Hydralazine	Minoxidil	Total
Arm/Group Description		25 mg Hydralazine taken twice daily...	2.5 mg Minoxidil taken twice daily ...	Total of all reporting groups
Arm/Group Description		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	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 of all reporting groups
Overall Number of Baseline Participants		0	2	2
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Number Unit of measure: Participants	Number Analyzed	0 participants	2 participants	2 participants
<=18 years			0	0
Between 18 and 65 years			1	1
>=65 years			1	1
Gender Measure Type: Number Unit of measure: Participants	Number Analyzed	0 participants	2 participants	2 participants
Female			1	1
Male			1	1
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	0 participants	2 participants	2 participants
United States			2	2

Outcome Measures

1.Primary Outcome


Title	Magnitude of Change in Blood Pressure
Description	[Not Specified]
Description	[Not Specified]
Time Frame	21 days

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Hydralazine	Minoxidil
Arm/Group Description:	25 mg Hydralazine taken twice daily...	2.5 mg Minoxidil taken twice daily ...
Arm/Group Description:	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	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 Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	21 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Hydralazine		Minoxidil
Arm/Group Description	25 mg Hydralazine taken twice daily...		2.5 mg Minoxidil taken twice daily ...
Arm/Group Description	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		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
All-Cause Mortality
	Hydralazine		Minoxidil
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Hydralazine		Minoxidil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0		0/2 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Hydralazine		Minoxidil
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0		1/2 (50.00%)
Gastrointestinal disorders
diarrhea (grade 1) ^†	0/0	0	1/2 (50.00%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

This study enrolled only 2 subjects and due to poor accrual, enrollment was stopped early. Due to the limited number of subjects available results cannot be assessed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Michael Maitland, MD, PhD
Organization:	University of Chicago
Phone:	773-702-4400
EMail:	mmaitlan@medicine.bsd.uchicago.edu

Layout table for additonal information

Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00607477
Other Study ID Numbers:	15386B
First Submitted:	January 22, 2008
First Posted:	February 5, 2008
Results First Submitted:	November 22, 2010
Results First Posted:	February 16, 2011
Last Update Posted:	June 10, 2014

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