Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial

Table 3 Evaluation of patient assessment questionnaire for edema (ITT analysis, N = 172)

Variable	Test group		Reference group		p*
Variable	N	Patient questionnaire score (mean ± sd)	N	Patient questionnaire score (mean ± sd)
Baseline (day 0), V1	86	00.00 ± 00.00	86	00.14 ± 01.02	na
After 30 days of therapy, V2	86	02.34 ± 05.23	86	02.07 ± 04.31	ns
After 60 days of therapy, V3	86	01.03 ± 03.34	86	02.29 ± 04.60	ns
After 90 days of therapy, V4	86	01.06 ± 03.41	86	01.81 ± 04.02	ns
After 120 days of therapy, V5	86	01.11 ± 03.35	86	02.60 ± 04.50	0.0363
p**		na		<0.0001

ITT intention to treat, N number of patients, V1-V5 visits 1–5, na not applicable, ns not significant
Mann-Whitney test was applied; *p value, when compared between the groups; **p value, when V5 value compared with baseline value in same group; p <0.05 = statistically significant

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