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NCT02125682: HDL PROTECT
Atorvastatin Action on Oxidative Stress and Inflammation in Type II Diabetes: The HDL Particle Protection Study
Phase 4 trial testing atovastatin 10 mg/day in Dyslipidemia in Patients With Diabetes Mellitus in 16 participants. Completed in 14 May 2017.
14 May 2017
Quick facts
| Lead sponsor | Hotel Dieu de France Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 1 January 2012 |
| Primary completion | 14 May 2017 |
| Estimated completion | 14 May 2017 |
| Sites | 1 location across Lebanon |
Drugs / interventions tested
- atovastatin 10 mg/day — full drug profile →
- Atorvastatin 80 mg/day — full drug profile →
Conditions studied
- Dyslipidemia in Patients With Diabetes Mellitus — all drugs for Dyslipidemia in Patients With Diabetes Mellitus →
Sponsor
Hotel Dieu de France Hospital
Who can join
Adults 21 to 80, any sex, with Dyslipidemia in Patients With Diabetes Mellitus.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
effect on HDL function
Time frame: 8 weeks
Does atorvastatin 80 mg/day improve HDL function more than 10 mg/day. HDL function will be assessed via several tests
Sponsor's own description
Atorvastatin is a statin that significantly decreases LDL level. At 10 mg/day, atorvastatin increases HDL level by 4-5%. At 80 mg/day, atorvastatin does not increase HDL level. However, atorvastatin is more protective at 80 mg/day than at 10 mg/day. This is due to a better reduction in LDL level at 80 mg, but we also think that 80 mg/day of atorvastatin is superior to 10 mg/day in improving the QUALITY of HDL, such as improving HDL particle number and function (better anti-oxydant activity)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02125682
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Hotel Dieu de France Hospital trials
Trials by the same sponsor.
- NCT07292909 — Effect of Empagliflozin on Inflammation · Phase 4 · recruiting
- NCT06917768 — Oral Corticosteroids' Role in Pediatric Obstructive Sleep Apnea · NA · completed
- NCT03578042 — Fixed-Free HTN Trial · Phase 4 · unknown
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 NCT02125682 (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 Hotel Dieu de France Hospital
- Last refreshed: 30 January 2018
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/NCT02125682.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing