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Pioglitazone Tablets Specified Drug-use Survey

Information source: Takeda
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Pioglitazone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Takeda

Official(s) and/or principal investigator(s):
Postmarketing Group Manager, Study Chair, Affiliation: Takeda

Summary

The purpose of this survey is to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction.

Clinical Details

Official title: Actos Tablets Specified Drug-use Survey

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Changes from baseline in laboratory parameters

Changes from baseline in laboratory parameters characteristics at the time of enrollment

Change in the rate of patients achieving good glycemic control (i.e., reduction in HbA1c values < 6.5%)

Blood glucose-related laboratory parameters at each time point

Secondary outcome: Frequency of adverse events

Detailed description: This survey was designed to evaluate the effects on glycemic control and to evaluate the safety of long-term use of pioglitazone tablets (Actos Tablets) in type 2 diabetic patients with inadequate glycemic control and a prior history of cerebral infarction. For adults, 15-30 mg of pioglitazone is usually administered orally once daily before or after breakfast. The dose should be adjusted depending on sex, age, and symptoms; however, the maximum daily dose should not exceed 45 mg.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetic patients with a prior history of cerebral infarction who meet all the

following conditions, [1] to [3], at the time of enrollment in the survey: 1. First onset of cerebral infarction was at least 24 weeks prior to enrollment 2. HbA1c values ≥ 6. 5% within 12 weeks prior to the start of treatment with Actos Tablets 3. No prior history of treatment with Actos Tablets since the first onset of cerebral infarction Exclusion Criteria:

- Patients who meet any of the following conditions, [1] to [5], shall be excluded from

the survey: 1. Contraindication for Actos Tablets 2. Prior history of recurrence of cerebral infarction 3. Prior history of cerebral hemorrhage or subarachnoid hemorrhage 4. Complications or prior history of myocardial infarction, angina pectoris, cardiomyopathy, hypertensive heart disease, atrial fibrillation, atrial flutter, or valvular disease 5. Reduced cardiac function (defined as an ejection fraction [EF] ≤ 40%)

Locations and Contacts

Additional Information

Starting date: January 2009
Last updated: July 2, 2014

Page last updated: August 20, 2015

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