This PMS study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market: 1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs)) 2. Frequency of incidence and its change in adverse events (AEs) 3. Factors on the safety profile of the study drug 4. Factors on the efficacy profile of the study...
Date First Received: January 30, 2008
Last Updated: June 12, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, June 2008
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Completed
Estimated Enrollment: 600
Brief Summary
Official Title: “Regulatory Drug Safety Survey”
Condition Keyword(s):
This PMS study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:
1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
2. Frequency of incidence and its change in adverse events (AEs)
3. Factors on the safety profile of the study drug
4. Factors on the efficacy profile of the study drug
Study Type: Observational
Study Design: N/A
Criteria for Participation in this Clinical Trial
INCLUSION CRITERIA:
- diagnosed as osteoarthritis and rheumatoid arthritis
EXCLUSION CRITERIA:
- 1. Known hypersensitivity to meloxicam
- 2. Cross hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs
- 3. Symptoms of asthma, rhinitis, angioneurotic edema, or urticaria following the administration of aspirin or other NSAIDs
- 4. Active peptic ulceration
- 5. Severe hepatic failure.
- 6. Non-dialysed severe renal insufficiency
- 7. Children and adolescents aged 15 years or less
- 8. Pregnancy or breastfeeding
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 15 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair B.I. Korea Ltd.
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00612885
Study ID Number: 107.270
ClinicalTrials.gov Identifier: NCT00612885
Health Authority: Korea, Republic of: KOREA Food and Drug Administration (KFDA)
Clinical Trials Authorship and Review
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