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The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study

NCT01622777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-06-20

No results posted yet for this study

Summary

To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.

Conditions

  • Diabetic Polyneuropathy

Interventions

DRUG

Rosuvastatin

20 mg daily of oral rosuvastatin for 12 weeks

DRUG

Placebo

100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks

Sponsors & Collaborators

  • Alejandra Guillermina Miranda Diaz

    lead OTHER

Principal Investigators

  • Ernesto G. Cardona-Muñoz, MD, PhD · University of Guadalajara

  • Luis Miguel Roman-Pintos, MD,PhD · University of Guadalajara

  • Rogelio Troyo-Sanroman, PhD · University of Guadalajara

  • María del Pilar Alatorre-Carranza, PhD · Hospital Civil de Guadalajara

  • Alejandra G. Miranda-Diaz, MD, PhD · University of Guadalajara

  • Jaime Hernandez-Ojeda, MD, PhD · University of Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-01-31
Completion
2011-06-30

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

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 NCT01622777 on ClinicalTrials.gov