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Brain SPECT Following Cialis (Tadalafil ) Administration (CIALIS)

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ClinicalTrials.gov Identifier: NCT01374347
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Mordechai Lorberboym Prof, Wolfson Medical Center

Brief Summary:
The study will be an open label one and will include 30 patients who underwent ischemic stroke 3 month to 3 years prior to the study. All patients will undergone a baseline brain SPECT perfusion study. 15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.

Condition or disease
Change in Brain Perfusion

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain SPECT Perfusion Imaging Following Cialis (Tadalafil ) Administration in Patients With Vascular Risk Factors
Study Start Date : May 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Group/Cohort
One dose, Repeat doses
First group recives one dose Second group receives several doses
One dose, several doses
15 patients will take one dose of 20 mg cialis, and will have a second brain SPECT 24 hours after cialis administration. 15 other patients (age and risk factor matched) will be prescribed 5 mg of cialis once daily for 7 days, and a second SPECT study will be performed 24 hours after the last dose.




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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female patients in the age range of 35-75 years.
Criteria

Inclusion Criteria:

  • Male and female patients in the age range of 35-75 years.

Exclusion Criteria:

  1. known allergic reaction to TF
  2. Medical contraindication to use TF
  3. Hemorrhagic stroke including intracerebral hemorrhage and subarachnoid hemorrhage
  4. Acute stroke or cardiac ischemic event up to 3 month prior to study.
  5. Other neurological brain diseases including degenerative diseases, multiple sclerosis, brain tumors, post severe brain injury (TBI) and migraine headache.
  6. Sensory aphasia.
  7. Cognitive impairment with disability to sign a consent form.Patients' Assessment

Responsible Party: Mordechai Lorberboym Prof, PI, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01374347     History of Changes
Other Study ID Numbers: 0044-11 WOMC
First Posted: June 15, 2011    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents