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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05106179
Other study ID # S_Hemangioma
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date December 2021
Est. completion date December 2023

Study information

Verified date November 2021
Source Center for Vascular Pathology, Moscow
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Spinal hemangioma is one of the most common benign vertebral tumours. Being mostly asymptomatic, it is still associated with a pain syndrome especially if encroaches into the neural canal. This study is organised to evaluate the efficacy and safety of β-blockers drugs in adults with spinal hemangioma.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date December 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - vertebral hemangioma Exclusion Criteria: - symptomatic bradycardia - AV block - decompensated heart failure - asthma

Study Design


Intervention

Drug:
Atenolol Pill
Atenolol is a second-generation hydrophilic ß-1-selective adrenergic antagonist, which is primarily metabolised by the kidneys.
Propranolol Pill
Propranolol is highly lipophilic, nonselective ß-blockers, which is primarily metabolised by the liver.

Locations

Country Name City State
Russian Federation The Vascular Anomalies Center (VAC) "Hemangioma" Moscow

Sponsors (1)

Lead Sponsor Collaborator
Center for Vascular Pathology, Moscow

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reducing tumor growth MRI 3 months
Primary Reducing tumor MRI 6 months
Primary Life-quality Valid questionnaires based on the ones, approved by EuroQol Organization 3 months and 6 months
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