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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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydralazine Minoxidil
Hide 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
Arm/Group Title Hydralazine Minoxidil Total
Hide 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
Hide 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
2 2
1.Primary Outcome
Title Magnitude of Change in Blood Pressure
Hide Description [Not Specified]
Time Frame 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
No participants analyzed due to poor accrual and insufficient numbers of participants.
Arm/Group Title Hydralazine Minoxidil
Hide 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.
Time Frame 21 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydralazine Minoxidil
Hide 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   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hydralazine Minoxidil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide 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
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Michael Maitland, MD, PhD
Organization: University of Chicago
Phone: 773-702-4400
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00607477     History of Changes
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