Table 1 Baseline characteristics and demographics in the safety analysis set

From: Nifedipine controlled-release 40 mg b.i.d. in Japanese patients with essential hypertension who responded insufficiently to nifedipine controlled-release 40 mg q.d.: a phase III, randomized, double-blind and parallel-group study

 

Nifedipine CR 40 mg b.i.d. (N=177)

Nifedipine CR 40 mg q.d. (N=175)

Total (N=352)

Age, years

 Mean±s.d.

55.3±10.2

54.2±10.1

54.7±10.1

 Range

33–85

29–82

29–85

Age group, n (%)

 <65 years

143 (80.8)

150 (85.7)

293 (83.2)

65 years

34 (19.2)

25 (14.3)

59 (16.8)

Sex, n (%)

 Male

125 (70.6)

137 (78.3)

262 (74.4)

 Female

52 (29.4)

38 (21.7)

90 (25.6)

Bodyweight, kg

 Mean±s.d.

70.3±12.6

72.6±15.1

71.5±14.0

 Range

42.0–120.4

41.6–133.9

41.6–133.9

Body mass index, kg m −2

 Mean±s.d.

25.8±3.5

26.2±4.3

26.0±3.9

 Range

17.9–36.9

14.1–50.1

14.1–50.1

Duration of hypertension, years

 Mean±s.d.

7.7±7.5

6.6±6.1

7.1±6.9

 Range

0.1–43.2

0.1–30.2

0.1–43.2

DBP, mm Hg

 Mean±s.d.

95.3±6.1

95.6±6.2

95.5±6.1

 Range

83–109

85–109

83–109

SBP, mm Hg

 Mean±s.d.

148.7±11.4

146.4±11.7

147.5±11.6

 Range

125–178

117–178

117–178

Pulse rate (beats min−1)a

 Mean±s.d.

75.8±9.6

75.7±10.8

 

 Range

53–98

52–117

 

Comorbid conditions, n (%)

 DM

20 (11.3)

16 (9.1)

36 (10.2)

 CKD

8 (4.5)

4 (2.3)

12 (3.4)

 pMI

1 (0.6)

1 (0.6)

2 (0.6)

Previous hypertension therapy, n (%)

 Calcium-channel blockers

149 (84.2)

148 (84.6)

297 (84.4)

 RAS agents

70 (39.5)

62 (35.4)

132 (37.5)

 β-blockers

6 (3.4)

5 (2.9)

11 (3.1)

 Antihypertensives

5 (2.8)

1 (0.6)

6 (1.7)

 Diuretics

3 (1.7)

3 (1.7)

6 (1.7)

 Serum lipid reducing agents

2 (1.1)

3 (1.7)

5 (1.4)

 Urologicals

4 (2.3)

1 (0.6)

5 (1.4)

Smoking status, n (%)

 Non-smoker

83 (46.9)

75 (42.9)

158 (44.9)

 Previous or present smoker

94 (53.1)

100 (57.1)

194 (55.1)

  1. Abbreviations: b.i.d., twice daily; CKD, chronic kidney disease; DBP, diastolic blood pressure; DM, diabetes mellitus; n, number of patients; N, total number of patients evaluated; pMI, prior myocardial infarction; q.d., once daily; RAS, renin-angiotensin system; SBP, systolic blood pressure.
  2. All patients enrolled in this study were Japanese outpatients.
  3. aAssessed in the full analysis set (N=351)