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Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

NCT04882293 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2022-03-02

No results posted yet for this study

Summary

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

Conditions

  • Dyslipidemia Associated With Type II Diabetes Mellitus

Interventions

DRUG

Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose

1 tablet once a day, 20 mg /160 mg, Orally

DRUG

Atorvastatin (Lipitor ®)

1 tablet once a day, 20 mg, Orally

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Alberto J Zamora Muciño-Arroyo, M.D · Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-AGS)

  • Joel Rodríguez Saldaña, M.D · Resultados médicos, desarrollo e investigación SC (REMEDI)

  • Francisco G Padilla Padilla, M.D · Independent

  • Juan A Peraza Zaldivar, M.D · Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V. (BIOMED-GDL)

  • Luis M Román Pintos, PhD · Hospital Hispano S.A de C.V

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882293 on ClinicalTrials.gov