Safety and Efficacy of L-NAME and Midodrine to Increase MAP
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00835224|
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : April 23, 2014
Last Update Posted : April 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Orthostatic Hypotension Spinal Cord Injury||Drug: L-NAME Drug: Midodrine Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of L-NAME and Midodrine to Increase MAP in Persons With Tetraplegia|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||August 2013|
A drug to treat low blood pressure.
To treat low blood pressure.
L-Name: A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension.
A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension.
Placebo Comparator: Placebo
Placebo: A pill with an inactive substance that looks like the study drug.
A pill with an inactive substance that looks like the study drug.
- Blood Pressure [ Time Frame: Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835224
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Jill Wecht, EdD||VA Medical Center, Bronx|