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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067391
• Other study ID #: Cialis 2009
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2010
• Last updated: July 16, 2015
• Start date: October 2009
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypotension
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• tadalafil
20 mg tablet, administered once per study protocol
• placebo
placebo tablet administered once per study protocol

Locations

Country	Name	City	State
Canada	Health Sciences Centre Rehabilitation Hospital	Winnipeg	Manitoba

Sponsors (3)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Medical Service Foundation, Rick Hansen Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes