A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)

Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24

Time frame: Week 24

Change in Total Alcohol Consumption (TAC) From Baseline at Week 12

Time frame: Week 12

Change in Total Alcohol Consumption (TAC) From Baseline at Week 24

Time frame: Week 24

Response Shift Drinking Risk Level (RSDRL) at Week 12

Proportion of patients with a downward shift in drinking risk level of two categories or more

Time frame: Week 12

Response Shift Drinking Risk Level (RSDRL) at Week 24

Proportion of patients with a downward shift in drinking risk level of two categories or more

Time frame: Week 24

Response Low Drinking Risk Level (RLDRL) at Week 12

Proportion of patients with low or lower drinking risk level

Time frame: Week 12

Response Low Drinking Risk Level (RLDRL) at Week 24

Proportion of patients with low or lower drinking risk level

Time frame: Week 24

70% TAC Responder Rate at Week 12

Proportion of patients with a 70% decrease in TAC

Time frame: Week 12

70% TAC Responder Rate at Week 24

Proportion of patients with a 70% decrease in TAC

Time frame: Week 24

HDD Responder Rate at Week 12

Proportion of patients with ≤4 HDDs

Time frame: Week 12

HDD Responder Rate at Week 24

Proportion of patients with ≤4 HDDs

Time frame: Week 24

Change in CGI-S From Baseline at Week 12

The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).

Time frame: Week 12

Change in CGI-S From Baseline at Week 24

The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).

Time frame: Week 24

Change in CGI-I From Baseline at Week 12

The CGI-I scale is used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

Time frame: Week 12

Change in CGI-I From Baseline at Week 24

The CGI-I scale was used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

Time frame: Week 24

Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12

All-patients-randomised set

Time frame: Week 12

Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24

All-patients-randomised set

Time frame: Week 24

Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12

All-patients-randomised set

Time frame: Week 12

Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24

All-patients-randomised set

Time frame: Week 24