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NCT00739999
A 8-Week, Open-Label, Phase 1 Study To Evaluate Pharmacokinetics, Pharmacodynamics, Safety And Tolerability Of Atorvastatin In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Phase 1 trial testing Atorvastatin in Pediatric Heterozygous Hypercholesterolemia in 39 participants. Completed in 1 May 2009.
1 May 2009
Quick facts
| Lead sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 39 |
| Start date | 1 December 2008 |
| Primary completion | 1 May 2009 |
| Estimated completion | 1 May 2009 |
| Sites | 3 locations across Canada, Greece, Norway |
Drugs / interventions tested
- Atorvastatin (atorvastatin) — full drug profile →
- Atorvastatin (atorvastatin) — full drug profile →
Conditions studied
- Pediatric Heterozygous Hypercholesterolemia — all drugs for Pediatric Heterozygous Hypercholesterolemia →
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. — full company profile →
Who can join
Adults 6 to 17, any sex, with Pediatric Heterozygous Hypercholesterolemia. 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.
-
Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F)
Time frame: Week 2, Week 4, Week 6, Week 8
Parent-metabolite population PK model built using sparse blood samples from both Tanner Stage 1 and Tanner Stage 2+. Blood sampling times: Weeks 2 and 6: single sample between 4 and 12 hours postdose; Weeks 4 and 8: predose, 1 hour, and 2 hours postdose. Plasma samples were analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using a validated, sensiti -
Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Apparent Volume of Distribution of the Central Compartment (Vc/F)
Time frame: Week 2, Week 4, Week 6, Week 8
Parent-metabolite population PK model built using sparse blood samples from Tanner Stages 1 and 2+. Sampling times: Weeks 2 + 6: single sample between 4 -12 hours postdose; Weeks 4 + 8: predose, 1 + 2 hours postdose. Plasma samples analyzed for atorvastatin and active hydroxyacid metabolite (o-hydroxyatorvastatin) concentrations using validated, sensitive, specific high-performance liquid chromato
Sponsor's own description
To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in children and adolescents with heterozygous familial hypercholesterolemia
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
An eight-week trial investigating the efficacy and tolerability of atorvastatin for children and adolescents with heterozygous familial hypercholesterolemia.
Gandelman K, Glue P, Laskey R, Jones J, et al · · 2011 · cited 20× · PMID 21259004 · DOI 10.1007/s00246-011-9885-z
Verify or expand the search:
- PubMed search for NCT00739999
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT00739999 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Last refreshed: 17 February 2021
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/NCT00739999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing