CompletedPhase 4

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

Canada20 participantsStarted 2009-10

Plain-language summary

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.

Who can participate

Age range18 Years – 70 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Supine and sitting blood pressure and heart rate (HR), as well as perceived dizziness upon sitting up.

Timeframe: Pre-dose, 1 hour, 2, 4, 12, 22, 29 and 36 hours post-dose.

Trial details

NCT IDNCT01067391

SponsorUniversity of Manitoba

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

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