Genome-wide Analysis of Lipid-lowering Efficacy and Drug Level of Simvastatin and Rosuvastatin

NCT04921657 | Completed FDA Drug

• 1 other identifier: GWAS
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 1

Brief Summary

This study will perform a genome-wide association study (GWAS) of the lipid responses to rosuvastatin and simvastatin and plasma concentrations of these two statins in a homogeneous group of Han Chinese patients.

Conditions

Hypercholesterolemia

Keywords

Statins; Pharmacogenomics

Outcome Measures

Primary Outcomes (1)

• Genome-wide analysis of DNA sample

  Presence or absence of single-nucleotide polymorphisms (SNPs) at over 700,000 points on the DNA samples will be analyzed using a whole-genome scan with the Illumina Omini Express BeadChip to identify which of these SNPs are associated with the LDL cholesterol reduction with rosuvastatin.

  DNA samples taken after 4 weeks on statin treatment.

Study Arms (1)

Patients treated with statin.

Patients with hypercholesterolemia treated with rosuvastatin 10 mg daily or simvastatin 40 mg daily.

Drug: Rosuvastatin 10mg

Interventions

Rosuvastatin 10mg DRUG

Also known as: Simvastatin 40 mg

Patients treated with statin.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypercholesterolemia attending medical clinics in Hong Kong who were eligible for statin treatment according to local guidelines in Hong Kong and willing to give informed consent for DNA analysis.

You may qualify if:

• Clinical diagnosis of hypercholesterolemia (familial or non-familial)
• Eligible for statin treatment according to local guidelines in the Hong Kong Public Hospital system.

You may not qualify if:

• Taking other medication which may interact with the pharmacokinetics or lipid response to statins.
• Not willing to cooperate with study requirements.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Brian Tomlinson

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium; Simvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds

Study Officials

• BRIAN TOMLINSON, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 10, 2021
• Study Start: November 1, 2014
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

HK (1)