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Thiazolidinedione

Pioglitazone 45 mg for Stroke

Phase 1 & 2
Waitlist Available
Led By Kerstin Bettermann, MD, PhD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours, 48 hours, and 90 days poststroke
Awards & highlights

Study Summary

This trial will test whether giving Pioglitazone to people who have had a stroke will improve their outcomes.

Eligible Conditions
  • Stroke
  • High Blood Sugar
  • Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours, 48 hours, and 90 days poststroke
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 48 hours, and 90 days poststroke for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Degree of Disability or Dependence in the Daily Activities
Neurological Status
Secondary outcome measures
Concentration of Markers of Neutrophil Activation and Function
Concentration of Stress Response Markers Including Cortisol, Norepinephrine and Epinephrine

Side effects data

From 2013 Phase 3 trial • 936 Patients • NCT01183013
10%
Oedema peripheral
9%
Hypertension
9%
Back pain
7%
Nasopharyngitis
7%
Hyperglycaemia
5%
Urinary tract infection
5%
Headache
4%
Pain in extremity
4%
Bronchitis
3%
Oedema
2%
Diarrhoea
2%
Arthralgia
2%
Upper respiratory tract infection
1%
Pneumothorax
1%
Pancreatitis acute
1%
Rectosigmoid cancer
1%
Hairy cell leukaemia
1%
Jaundice
1%
Myocardial infarction
1%
Intestinal haemorrhage
1%
Pneumonia
1%
Small intestine carcinoma
1%
Bipolar disorder
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pio15/Pio30
Pio30/Pio30
Pio45/Pio45
Lina5/Lina5
Lina5Pio15/Lina5Pio30
Lina5Pio30/Lina5Pio30
Lina5Pio45/Lina5Pio45

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pioglitazone treatment groupExperimental Treatment1 Intervention
oral administration of 45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
Group II: Placebo groupPlacebo Group1 Intervention
Oral administration of placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pioglitazone 45 mg
2000
Completed Phase 4
~960

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
494 Previous Clinical Trials
2,798,841 Total Patients Enrolled
3 Trials studying Stroke
18 Patients Enrolled for Stroke
Kerstin Bettermann, MD, PhD2.03 ReviewsPrincipal Investigator - Penn State College of Medicine
Milton S. Hershey Medical Center
1 Previous Clinical Trials
87 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke
Kerstin Bettermann 2020. "Pioglitazone Treatment for Hyperglycemic Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04123067.
~0 spots leftby Apr 2025
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