Last reviewed · How we verify
NCT02035215
Efficacy and Safety of Co-administration of Omacor Plus Atorvastatin Compared With Atorvastatin Monotherapy in Patients With Type Ⅱb Dyslipidemia: a Multicenter, Double-blind, Randomized, Active-controlled, Parallel, Phase Ⅲ Study
Phase 3 trial testing Atorvastatin 20mg in Hyperlipidemia, Familial Combined in 80 participants. Status unknown.
1 October 2014
Quick facts
| Lead sponsor | Kuhnil Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 January 2014 |
| Primary completion | 1 October 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 4 locations across South Korea |
Drugs / interventions tested
- Atorvastatin 20mg — full drug profile →
- Omega-3-acids ethylesters 90 4g — full drug profile →
- Placebo(Omega-3-acids ethylesters 90)
Conditions studied
- Hyperlipidemia, Familial Combined — all drugs for Hyperlipidemia, Familial Combined →
Sponsor
Kuhnil Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 20 to 80, any sex, with Hyperlipidemia, Familial Combined. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The mean percent change of Triglyceride(TG)
Time frame: from baseline at week 8
Sponsor's own description
The purpose of this study is to evaluate the efficacy and safety of combination therapy of omega-3-acids ethylesters 90/Atorvastatin calcium in type Ⅱb hyperlipidemia
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02035215
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Kuhnil Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT03482180 — Evaluate the Efficacy and Safety of KI1106 in Patients Whose TG Level is Not Adequately Controlled With Atorvastatin Cal · Phase 3 · completed
- NCT01813253 — Phase 3 Study of Nimotuzumab and Irinotecan as Second Line With Advanced or Recurrect Gastric and Gastroesophageal Junct · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02035215 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kuhnil Pharmaceutical Co., Ltd.
- Last refreshed: 19 March 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02035215.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing