21973
document
Results of a multicenter , 8-week , parallel-group , randomized , double-blind , double-dummy , Phase III clinical trial to evaluate the efficacy and tolerability of amlodipine maleate versus amlodipine besylate in Korean patients with mild to moderate hypertension . BACKGROUND Recently , amlodipine maleate was developed and tested in preclinical and Phase I clinical trials in Korea . The studies found pharmacokinetics and pharmacodynamics similar to those of amlodipine besylate . OBJECTIVE The aim of this study was to compare the efficacy and tolerability of amlodipine maleate with those of amlodipine besylate in Korean patients with mild to moderate hypertension . METHODS This was a multicenter , 8-week , parallel-group , randomized , double-blind , double-dummy , Phase III clinical trial . Eligible patients were Korean , aged 18 to 75 years , had hypertension , and were either taking antihypertensive medications or had a documented sitting diastolic blood pressure of 90 to 109 mm Hg . After a washout period of 2 weeks , patients were randomized to amlodipine maleate or amlodipine besylate for 8 weeks . In both groups , the medications were initiated at 5 mg QD . At day 29 , the medication dose was increased to 10 mg QD if sitting diastolic blood pressure ( SiDBP ) was > or = 90 mm Hg . RESULTS One hundred eighteen patients were enrolled . Fifty-seven patients received amlodipine maleate ( 29 men , 28 women ; mean [ SD ] age , 49.0 [ 11.4 ] years ) and 61 received amlodipine besylate ( 35 men , 26 women ; mean [ SD ] age , 51.6 [ 9.4 ] years ) . Baseline mean ( SD ) values for sitting systolic blood pressure and SiDBP were 152.0 ( 12.2 ) mm Hg and 98.1 ( 5.6 ) mm Hg , respectively , for the amlodipine maleate group and 153.4 ( 14.0 ) mm Hg and 98.1 ( 5.5 ) mm Hg , respectively , for the amlodipine besylate group . In this population , amlodipine maleate was not inferior to amlodipine besylate : the lower limit of the 2-sided 95 % CI for the treatment difference in SiDBP was greater than -4 mm Hg . The between-group difference in SiDBP response rate ( the proportion of patients who experienced adequate SiDBP reductions ) did not reach statistical significance : 85.7 % ( 42/49 ) for the amlodipine maleate group and 91.8 % ( 45/49 ) for the amlodipine besylate group . Compliance rates were similar between groups , with mean ( SD ) compliance rates of 97.4 % ( 2.8 % ) and 97.1 % ( 3.6 % ) in the amlodipine maleate and amlodipine besylate groups , respectively . Also , there were no significant differences in the incidences of drug-related clinical and laboratory adverse events ; the most common were headache , flushing , facial edema , and paresthesia . CONCLUSION In this population , the efficacy and tolerability observed with amlodipine maleate were similar to those seen with amlodipine besylate .
21974
Intervention_Pharmacological
amlodipine maleate versus amlodipine besylate
21975
Intervention_Pharmacological
amlodipine maleate
21976
Intervention_Pharmacological
amlodipine besylate
21977
Intervention_Pharmacological
amlodipine maleate
21978
Intervention_Pharmacological
amlodipine besylate
21979
Intervention_Pharmacological
amlodipine maleate or amlodipine besylate
21980
Intervention_Pharmacological
amlodipine maleate
21981
Intervention_Pharmacological
amlodipine besylate
21982
Intervention_Pharmacological
amlodipine maleate
21983
Intervention_Pharmacological
amlodipine besylate
21984
Intervention_Pharmacological
amlodipine maleate
21985
Intervention_Pharmacological
amlodipine besylate :
21986
Intervention_Pharmacological
amlodipine maleate
21987
Intervention_Pharmacological
amlodipine maleate
21988
Intervention_Pharmacological
amlodipine besylate
21989
Outcome_Physical
Baseline mean ( SD ) values
21990
Outcome_Physical
sitting systolic blood pressure and SiDBP
21991
Outcome_Physical
SiDBP
21992
Outcome_Physical
SiDBP response rate
21993
Outcome_Mental
mean ( SD ) compliance rates
21994
Outcome_Adverse-effects
headache , flushing , facial edema , and paresthesia .
21995
Participant_Condition
mild to moderate hypertension
21996
Participant_Condition
Korean patients
21997
Participant_Condition
mild to moderate hypertension
21998
Participant_Age
aged 18 to 75 years
21999
Participant_Condition
hypertension
22000
Participant_Condition
were either taking antihypertensive medications or had a documented sitting diastolic blood pressure of 90 to 109 mm Hg
22001
Participant_Sample-size
One hundred eighteen