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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Manitoba Medical Service Foundation
Rick Hansen Foundation
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01067391
First received: February 10, 2010
Last updated: April 27, 2011
Last verified: April 2011
History of Changes
  Purpose

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 Intervention Phase
Hypotension
Spinal Cord Injury
 Drug: tadalafil
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Drug Information available for: Tadalafil
U.S. FDA Resources

Further study details as provided by University of Manitoba:

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

Estimated Enrollment: 25
Study Start Date: October 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067391

Locations
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
Investigators
Principal Investigator: Karen D. Ethans, MD University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. Karen Ethans, Director, Spinal Cord Injury Rehabilitation Program, University of Manitoba, Health Sciences Centre, Winnipeg, Manitoba
ClinicalTrials.gov Identifier: NCT01067391     History of Changes
Other Study ID Numbers: Cialis 2009
Study First Received: February 10, 2010
Last Updated: April 27, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
Hypotension in SCI males
Erectile Dysfunction

Additional relevant MeSH terms:
Hypotension
Spinal Cord Injuries
Vascular Diseases
Cardiovascular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
 Tadalafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013