Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension

This study has been terminated.

( Study has been terminated due to poor accrual. )

Study NCT00607477 Information provided by University of Chicago

First Received on January 22, 2008. Last Updated on January 19, 2011 History of Changes

Results First Received: November 22, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Treatment Induced Hypertension
Interventions:	Drug: Minoxidil Drug: Hydralazine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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

Participant Flow: Overall Study

Baseline Characteristics

Reporting Groups

	Description
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

Baseline Measures

	Hydralazine	Minoxidil	Total
Number of Participants [units: participants]	0	2	2
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	0	1	1
>=65 years	0	1	1
Gender [units: participants]
Female	0	1	1
Male	0	1	1
Region of Enrollment [units: participants]
United States	0	2	2

Outcome Measures

1. Primary:

Time to and Magnitude of Change in Blood Pressure [ Time Frame: 21 days ]

Show Outcome Measure 1

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

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

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Michael Maitland, MD, PhD, University of Chicago
ClinicalTrials.gov Identifier:	NCT00607477 History of Changes
Other Study ID Numbers:	UCIRB 15386B
Study First Received:	January 22, 2008
Results First Received:	November 22, 2010
Last Updated:	January 19, 2011
Health Authority:	United States: Institutional Review Board