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EvolocumabWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)


Name (Synonyms) Correlation
drug2289 Spironolactone 100mg Wiki 0.50
drug142 Alirocumab Wiki 0.25
drug1853 Placebo oral tablet Wiki 0.09
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.05
D012127 Respiratory Distress Syndrome, Newborn NIH 0.05
D012128 Respiratory Distress Syndrome, Adult NIH 0.04

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 4 clinical trials

Clinical Trials


1 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

NCT04189484 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Placebo

Primary Outcomes

Description: The values and variability of AUEC for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under effect curve (AUEC) for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximum change from baseline for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Secondary Outcomes

Description: The values and variability of AUEC for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: AUEC for Apolipoprotein B (ApoB) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximal difference at a single time-point for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for apoB for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of Cmax at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum concentration (Cmax) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of AUC at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under the curve (AUC) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (Emax) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (maximum effect [Emax]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (EC50) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (half maximum effect concentration [EC50]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

2 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

NCT04189484 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Placebo

Primary Outcomes

Description: The values and variability of AUEC for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under effect curve (AUEC) for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximum change from baseline for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Secondary Outcomes

Description: The values and variability of AUEC for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: AUEC for Apolipoprotein B (ApoB) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximal difference at a single time-point for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for apoB for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of Cmax at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum concentration (Cmax) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of AUC at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under the curve (AUC) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (Emax) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (maximum effect [Emax]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (EC50) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (half maximum effect concentration [EC50]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

3 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

NCT04189484 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Placebo

Primary Outcomes

Description: The values and variability of AUEC for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under effect curve (AUEC) for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximum change from baseline for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Secondary Outcomes

Description: The values and variability of AUEC for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: AUEC for Apolipoprotein B (ApoB) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximal difference at a single time-point for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for apoB for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of Cmax at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum concentration (Cmax) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of AUC at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under the curve (AUC) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (Emax) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (maximum effect [Emax]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (EC50) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (half maximum effect concentration [EC50]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

4 Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 2: PCSK9 Inhibitors - Alirocumab and Evolocumab

This study is designed to assess pharmacokinetics and pharmacodynamics of evolocumab and alirocumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (evolocumab and alirocumab ) or placebo.

NCT04189484 Healthy Subjects Pharmacokinetics Pharmacodynamics Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Evolocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Alirocumab Biological: Placebo

Primary Outcomes

Description: The values and variability of AUEC for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under effect curve (AUEC) for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximum change from baseline for LDL-C at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for LDL-C for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Secondary Outcomes

Description: The values and variability of AUEC for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: AUEC for Apolipoprotein B (ApoB) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of maximal difference at a single time-point for ApoB at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum change from baseline for apoB for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of Cmax at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Maximum concentration (Cmax) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: The values and variability of AUC at low, intermediate low, intermediate high, and high doses of evolocumab and alirocumab

Measure: Area under the curve (AUC) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (Emax) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (maximum effect [Emax]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm

Description: Model parameters (EC50) calculated after combining data from low, intermediate low, intermediate high, and high doses of evolocumab or alirocumab with placebo data.

Measure: Pharmacodynamic model parameters (half maximum effect concentration [EC50]) for evolocumab and alirocumab

Time: 42, 56, or 84 days, depending on treatment arm


No related HPO nodes (Using clinical trials)