Effect of Tadalafil (Cialis) on the Cardiovascular System of Spinal Cord Injury (SCI) Males

Study Overview
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Brief Summary
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To address the effect of tadalafil (Cialis) on the cardiovascular system of men with complete spinal cord injury at T-6 and above. The hypothesis is that tadalafil will cause significant hypotension in people with tetraplegia.

Detailed Description
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Tadalafil is a long-acting PDE-5 inhibitor, used to treat erectile dysfunction (ED). ED is a common issue for males with spinal cord injury (SCI).Patients with SCI are at risk of developing orthostatic hypotension, especially those with an injury at or above the T-6 level.An earlier study of the shorter-acting PDE-5 inhibitor sildenafil (Viagra) revealed that it can cause orthostatic hypotension, tachycardia and dizziness after administration in the SCI population, and suggested that caution should be used in prescribing sildenafil in this population, as blood pressure can drop significantly. There is potential for the significant hypotension seen with the short-acting medications to be much more problematic with the longer-acting tadalafil. The study will be a prospective, randomized, double-blind, placebo-controlled cross-over design. This will be done by comparing the effects of administering tadalafil 20 mg and placebo on blood pressure (lying and sitting), and heart rate (lying and sitting). These measurements will be taken in the clinic setting prior to dosing, then repeated hourly for the first two hours post-dose, and again at four hours post-dose. The patient will repeat the measurements at home using an automated blood pressure apparatus at 12, 22,29 and 36 hours post-dose.In addition, the patient will record perceived dizziness on a visual analog scale ecah time the BP and HR are recorded.

Official Title
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A Randomized, Double-blind, Placebo-controlled Cross-over Trial Assessing the Effect of Tadalafil (Cialis) on the Cardiovascular System in Men With Complete Spinal Cord Injury (SCI) at or Above the Sixth Thoracic Level

Conditions
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Hypotension, Spinal Cord Injury

Intervention / Treatment
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* Drug: tadalafil
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males 18 to 70 years old, with complete spinal cord injury (ASIA-A) between C-4 and T-6 minimum 6 months post-injury Exclusion Criteria: diabetic taking nitroglycerin ischemic heart disease or significantly abnormal EKG lower motor neuron dysfunction heroin or cocaine use history of adverse reaction to tadalafil or any other PDE-5 inhibitor any condition that may put the subject at risk, confound the study results, or interfere significantly with subject's ability to participate in the study have used any other (PDE-5) medications within 1 week of study medication administration

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tadalafil 20 mg<br>Oral study medication to be administered once to each participant | Drug: tadalafil<br>* 20 mg tablet, administered once per study protocol<br>* Other names: Cialis;|
| Placebo Comparator: placebo<br>oral study medication to be administered once to each study participant | Drug: placebo<br>* placebo tablet administered once per study protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supine and sitting blood pressure and heart rate (HR), as well as perceived dizziness upon sitting up. |  | Pre-dose, 1 hour, 2, 4, 12, 22, 29 and 36 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypotension in SCI males, Erectile Dysfunction