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Clinical Trials/CTRI/2011/091/000030
CTRI/2011/091/000030
Other
Phase 4

A randomized, double blind, comparative, multicentric study evaluating efficacy and tolerability of Extended Release Niacin and Rosuvastatin vs Matching placebo and Rosuvastatin in patients with Mixed Dyslipidemia.

Troikaa Pharmaceuticals Ltd0 sites60 target enrollmentTBD
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ConditionsHealth Condition 1: null- Mixed Dyslipidemia

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Mixed Dyslipidemia
Sponsor
Troikaa Pharmaceuticals Ltd
Enrollment
60
Status
Other
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
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients in the age group of 18\-75 years suffering from Mixed dyslipidemia
  • •2\.Patients with LDL\-C level \> 130 mg/dL
  • •3\.Patients with HDL\-C level \< 40 mg/dL
  • •4\.Patients requiring Rosuvastatin therapy (already receiving Rosuvastatin or recently started)

Exclusion Criteria

  • •1\.Patient with history of hypersensitivity to any statin, niacin or aspirin
  • •2\.Patients with uncontrolled diabetes
  • •3\.Patients with clinically unacceptable laboratory parameters
  • •4\.Patients with peptic ulcer disease
  • •5\.Patients with history of bleeding or coagulation disorder
  • •6\.Patients requiring hospitalization
  • •7\.Patient with history of hypotension
  • •8\.Patients with compromised hepatic and renal function
  • •9\.Pregnant and lactating women
  • •10\.Women of child bearing age not practicing or not willing to use contraceptive

Outcomes

Primary Outcomes

Not specified

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