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

NCT01067391 | Completed Phase 4

• 1 other identifier: Cialis 2009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension; Spinal Cord Injury

Keywords

Hypotension in SCI males; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

tadalafil 20 mg

ACTIVE COMPARATOR

Oral study medication to be administered once to each participant

Drug: tadalafil

placebo

PLACEBO COMPARATOR

oral study medication to be administered once to each study participant

Drug: placebo

Interventions

tadalafil DRUG

20 mg tablet, administered once per study protocol

Also known as: Cialis

tadalafil 20 mg

placebo DRUG

placebo tablet administered once per study protocol

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• males 18 to 70 years old, with complete spinal cord injury (ASIA-A) between C-4 and T-6
• minimum 6 months post-injury

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator
• Rick Hansen Foundation: collaborator

Study Sites (1)

Health Sciences Centre Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Hypotension; Spinal Cord Injuries; Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Karen D. Ethans, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Spinal Cord Injury Rehabilitation Program

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 11, 2010
• Study Start: October 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 17, 2015

Record last verified: 2015-07

Locations

CA (1)