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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Spinal Cord Injury
• Intervention / Treatment: Drug: tadalafil; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M4
      • Health Sciences Centre Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Cialis
Placebo Comparator: placebo; oral study medication to be administered once to each study participant	Drug: placebo; placebo tablet administered once per study protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Manitoba Medical Service Foundation; Rick Hansen Foundation
• Investigators: Principal Investigator: Karen D. Ethans, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: February 10, 2010
• First Submitted That Met QC Criteria: February 10, 2010
• First Posted (Estimate): February 11, 2010

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 16, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Erectile Dysfunction; Hypotension in SCI males
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Hypotension; Spinal Cord Injuries; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: Cialis 2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No