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Clinical Trials/CTRI/2013/05/003686
CTRI/2013/05/003686
Not yet recruiting
Phase 4

A Post Marketing Surveillance study to assess the efficacy and safety of PIVASTA (Pitavastatin) Tablets in patients of Type 2 Diabetes mellitus and dyslipidemia

Cadila Healthcare0 sites500 target enrollmentTBD
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ConditionsHealth Condition 1: null- Diabetic Dyslipidemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Diabetic Dyslipidemia
Sponsor
Cadila Healthcare
Enrollment
500
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Pms

Investigators

Sponsor
Cadila Healthcare

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients of either sex, 18\-75 years of age..
  • •2\. Patients who are diagnosed of Type 2 Diabetes
  • •3\. Patients with any one of the following: serum Low density Lipoprotein (LDL) cholesterol \> 100 mg/dl, Or serum high density lipoprotein (HDL) cholesterol \< 40 mg/dl (for male), HDL \< 50 mg/dl (for female), Or serum triglycerides (TG) \> 150 mg/dl

Exclusion Criteria

  • •Patients who is:
  • •1\. Known to have hypersensitivity to pitavastatin
  • •2\. Having active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels
  • •3\. Pregnant woman or may become pregnant in next 3 months
  • •4\. Nursing mother
  • •5\. on cyclosporine
  • •6\. Has change/titration in anti\-diabetic medications in last one month
  • •7\. On statin or other lipid lowering therapy during last 3 months
  • •8\. creatinine clearance \< 30 ml/min/1\.73 m2
  • •9\. not willing to give written consent for enrollment in the study.

Outcomes

Primary Outcomes

Not specified

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