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Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients

NCT00316719 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2009-10-06

Study results available
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Summary

This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.

Conditions

Interventions

DRUG

LAM group

Subjects took one LAM 100mg tablet orally once daily and one ADV placebo tablet orally once daily.

DRUG

ADV group

Subjects took one ADV 10mg tablet orally once daily and one LAM placebo tablet orally once daily.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-01-31
Completion
2008-01-31

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Entities

Diseases
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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 NCT00316719 on ClinicalTrials.gov