Phase 1 N=32 Evaluate the Effect of Atorvastatin on the Pharmacokinetics of Lomitapide in Healthy Subjects.
Effect of Atorvastatin on the Pharmacokinetics of Lomitapide
Primary: Cmax — 0.940; 2.00; 2.24; 2.11 ng/mL
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=27 LY2189265 and Atorvastatin Interaction Study
Healthy Volunteers
Primary: Pharmacokinetics of Atorvastatin: Maximum Plasma Concentration (Cmax) — 19.5; 5.78 nanogram per milliliter (ng/mL)
Phase 1 N=24 Drug-Drug Interaction Study Between Colchicine and Atorvastatin
Healthy
Primary: Maximum Plasma Concentration (Cmax) of Colchicine — 2,023.29; 2,487.96 pg/mL
Phase 4 N=24 Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin
Healthy Volunteers
Primary: Area Under the Curve From Time 0 to Tau (AUC 0-τ) — 113.92 ng•h/mL
Phase 1 N=32 Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects
Healthy
Primary: Cmax for Arm 1 (Lomitapide & EE/Noregestimate - Taken Together) — 1.03; 1.39; 2.96; 2.95 ng/mL
Phase 1 N=15 Study to Determine the Intra-subject Variability of Pharmacokinetics of Lomitapide in Healthy Subjects
Intra-subject Variability of Pharmacokinetics
Primary: Cmax — 0.961; 2.34; 23.6; 1.02 ng/mL
Phase 2 N=6 Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor
Homozygous Familial Hypercholesterolemia
Primary: LDL-C — -50.94 percentage change in LDL-C
Phase 1 N=13 Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
Healthy Participants
Primary: Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin — 3.80; 6.47 ng/mL
Phase 3 N=9 Efficacy and Safety of Lomitapide in Japanese Patients With HoFH on Concurrent Lipid-Lowering Therapy
Familial Hypercholesterolemia - Homozygous
Primary: Percent Change in LDL-C — -42.2 Percent change
Phase 3 N=146 Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Hypercholesterolemia
Primary: Number of Participants With Adverse Events and Adverse Reactions — 141; 61 Participants
Phase 2 N=40 Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Hypercholesterolemia · Dyslipidemias
Primary: Efficacy, Number of Participants With Day 15 LDL-C Less Than or Equal to 125% of Baseline LDL-C — 9; 9; 1; 7 Participants
Phase 4 N=28 Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin
Healthy
Primary: NK-104 AUC — 192.00 ng * h/mL
Phase 1 N=72 Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
Healthy Volunteer
Primary: Cmax for Lomitapide — 0.570; 0.436; 1.70; 1.01 ng/mL
Phase 3 N=328 A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
Hypercholesterolemia
Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment — -58.9; -58.7 Percentage Change
Phase 2 N=220 Study of Atorvastatin/Fenofibrate (LCP-AtorFen) Combination Therapy in Dyslipidemia
Dyslipidemia
Primary: Percent Changes From Baseline to End-of-treatment in Non-HDL Cholesterol, HDL Cholesterol, and Triglycerides by LCP-AtorFen Versus Atorvastatin Monotherapy — -44.8…
Phase 4 N=10 Drug-Drug Interaction Between Rifampin and Fluvastatin
Drug-drug Interaction
Primary: AUC — 242; 642; 124; 371 ng/mL·h
Phase 1 N=18 STUDY TO EVALUATE THE EFFECT OF PF-06882961 ON SINGLE DOSE ATORVASTATIN, MEDAZOLAM AND ORALCONTRACEPTIVE PHARMACOKINETICS IN HEALTHY ADULT PARTICIPANTS
Healthy Adults
Primary: (Part A) Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of Atorvastatin in Periods 1, 4, and 7 — 32.27; 46.94; 54.43 nanogram*hour/milliliter…
Phase 1 N=51 Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Healthy
Primary: AUCτ,ss (Itraconazole Part) — 29900; 59500 ng*h/mL
Phase 3 N=2,340 Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
Mixed Hyperlipidemia
Primary: Percentage Change From Baseline in the LDL-C/HDL-C Ratio — -50.9; -53.0; -37.6; -42.4 Percentage Change — p=<0.001
Phase 4 N=125 Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)
Primary Hypercholesterolemia
Primary: Percent Change in Low-Density Lipoprotein - Cholesterol (LDL-C) Values — -25.8; -15.1; 0.8 Percent change — p=<0.0001
Phase 4 N=24 Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir
HIV · Dyslipidemia
Primary: Efficacy of Pitavastatin in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir — 239.9; 257.6; 282; 350 mg/dL — p=<0.05
Phase 2 N=6 A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
Dyslipidaemias · Dyslipidemias
Primary: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A — 0; 2; 0; 0 Participants
Phase 3 N=454 Ezetimibe (EZ)/Atorvastatin (Ator) (MK-0653C) vs. Ator in Chinese Hypercholesterolemic Participants (MK-0653C-439)
Hypercholesterolemia
Primary: Percent Change From Baseline in LDL-C at Week 12 — -24.7; -5.3; -23.3; -9.1 Percent change — p=<0.001
Phase 4 N=108 Systemic Immunomodulatory Effects and Pharmacogenetics of Atorvastatin in Early Atherosclerosis
Inflammation
Primary: Mean Change in Level: Week 16-baseline in Ena-78 — -111.2 pg/ml — p=0.15
Phase 1 N=30 Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects
Epilepsy
Primary: Simvastatin Cmax (Maximum Plasma Concentration) — 17.7; 6.89 ng/mL
Phase 2 N=111 Study Of The Effects Of Atorvastatin On Cholesterol Levels In Rheumatoid Arthritis Patients Taking CP-690,550
Rheumatoid Arthritis
Primary: Percent Change From Baseline (Week 6) in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Week 12 — -35.34; 5.80 percent change
Phase 3 N=406 A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
Hypercholesterolemia
Primary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) After 6 Weeks of Treatment — -54.0; -53.8 Percentage Change
Phase 2 N=17 Darunavir/Ritonavir and Rosuvastatin Pharmacokinetic Study
HIV Infections
Primary: Cmax of Rosuvastatin — 6.70; 16.32 ng/mL
Phase 1 N=32 A Comparative Bioavailability Study of Lomitapide 20 mg Intact vs Sprinkled
Healthy
Primary: AUC0-t — 38.3; 40.2; 43.6; 70.4 ng*h/mL
Phase 1 N=39 8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Pediatric Heterozygous Hypercholesterolemia
Primary: Parent-metabolite Population Pharmacokinetic (PK) Model for Atorvastatin and Its Metabolites: Atorvastatin Apparent Clearance (CL/F) — 553; 543 L/hr