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

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. Identifier: NCT01067391
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : July 17, 2015
Manitoba Medical Service Foundation
Rick Hansen Foundation
Information provided by (Responsible Party):
Dr. Karen Ethans, University of Manitoba

Brief 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.

Condition or disease Intervention/treatment Phase
Hypotension Spinal Cord Injury Drug: tadalafil Drug: placebo Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
Active Comparator: tadalafil 20 mg
Oral study medication to be administered once to each participant
Drug: tadalafil
20 mg tablet, administered once per study protocol
Other Name: Cialis

Placebo Comparator: placebo
oral study medication to be administered once to each study participant
Drug: placebo
placebo tablet administered once per study protocol

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01067391

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Canada, Manitoba
Health Sciences Centre Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1M4
Sponsors and Collaborators
University of Manitoba
Manitoba Medical Service Foundation
Rick Hansen Foundation
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Principal Investigator: Karen D. Ethans, MD University of Manitoba
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Responsible Party: Dr. Karen Ethans, Director, Spinal Cord Injury Rehabilitation Program, University of Manitoba Identifier: NCT01067391    
Other Study ID Numbers: Cialis 2009
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: July 17, 2015
Last Verified: July 2015
Keywords provided by Dr. Karen Ethans, University of Manitoba:
Hypotension in SCI males
Erectile Dysfunction
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Vascular Diseases
Cardiovascular Diseases
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents