Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Study has been terminated due to poor accrual.)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00607477
First received: January 22, 2008
Last updated: June 3, 2014
Last verified: June 2014
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
  Hide 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
    Hydralazine     Minoxidil  
STARTED     0     2  
COMPLETED     0     2  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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
Total Total of all reporting groups

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



  Outcome Measures

1.  Primary:   Magnitude of Change in Blood Pressure   [ Time Frame: 21 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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
e-mail: mmaitlan@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00607477     History of Changes
Other Study ID Numbers: 15386B
Study First Received: January 22, 2008
Results First Received: November 22, 2010
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board