The Phase III, double-blind, parallel-group controlled study of amlodipine 10 mg once daily in Japanese patients with essential hypertension who insufficiently responded to amlodipine 5 mg once daily.
The objective of this Phase III double-blind parallel-group controlled study was to examine the superiority of amlodipine 10 mg once daily (the amlodipine 10 mg group) to amlodipine 5 mg once daily (the amlodipine 5 mg group) in 305 Japanese outpatients with essential hypertension whose systolic blood pressure (SBP) had not reached the therapeutic target levels (<130-140/80-90 mm Hg) when treated with amlodipine 5 mg once daily. This study consisted of the 1-week prescreening, 8-week screening and 8-week double-blind periods. Changes in trough SBP from baseline at week 8 of the double-blind period (week 8) were -7.0 mm Hg and -13.7 mm Hg in the amlodipine 5 and 10 mg groups, respectively; a significant difference (P<0.001) was found between the two groups. Changes in trough diastolic blood pressure (DBP) from baseline at week 8 were -2.7 mm Hg and -6.8 mm Hg in the amlodipine 5 and 10 mg groups, respectively, with a significant difference (P<0.001) between the two groups. At week 8, responder rates were 28.5 and 44.0% in the amlodipine 5 mg and 10 mg groups, respectively, with a significant difference (P=0.002) between the two groups. The amlodipine 10 mg group showed no significant difference in the incidences of adverse events against the amlodipine 5 mg group. The incidence of mild peripheral oedema was 4% only in the amlodipine 10 mg group. In conclusion, amlodipine 10 mg once daily was found to be superior to amlodipine 5 mg once daily, safe, well tolerated and useful for the relevant subjects.
Fujiwara
T
T
Tokyo Laboratories, Pfizer Global R&D, Pfizer Japan Inc., Pfizer K.K., 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-8589, Japan. tadami.fujiwara@pfizer.com
Ii
Y
Y
Hatsuzawa
J
J
Murase
H
H
Watanabe
T
T
Murakami
M
M
Kimura
N
N
Buch
J
J
Tsuchihashi
T
T
Saruta
T
T
D000328:Adult; D000368:Aged; D017311:Amlodipine / Q000008:administration & dosage* / Q000009:adverse effects; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001794:Blood Pressure / Q000187:drug effects; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004487:Edema / Q000139:chemically induced; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D007564:Japan; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D017311:Amlodipine