Skip to main content

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

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

Variable Test group Reference group p*
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  
  1. ITT intention to treat, N number of patients, V1-V5 visits 1–5, na not applicable, ns not significant
  2. 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