Full Text View
Tabular View
Study Results
Related Studies
Trial Comparing Tiotropium Inhalation Capsules vs Placebo in Chronic Obstructive Pulmonary Disease (COPD).
This study has been completed.
Study NCT00523991   Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on July 9, 2007.   Last Updated on November 25, 2011   History of Changes
Results First Received: July 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: tiotropium
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
Tiotropium 18 mcg tiotropium via HandiHaler® + PRN albuterol

Participant Flow:   Overall Study
    Placebo     Tiotropium  
STARTED     219     238  
COMPLETED     198     211  
NOT COMPLETED     21     27  
Adverse Event                 6                 5  
Protocol Violation                 1                 4  
Lost to Follow-up                 4                 1  
Withdrawal by Subject                 7                 17  
Other reason (not specified)                 3                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Placebo Placebo matching tiotropium via HandiHaler® + PRN albuterol
Tiotropium 18 mcg tiotropium via HandiHaler® + PRN albuterol

Baseline Measures
    Placebo     Tiotropium     Total  
Number of Participants  
[units: participants]
 		  219     238     457  
Age  
[units: years]
Mean ± Standard Deviation 		  62.3  ± 8.6     61.2  ± 8.2     61.7  ± 8.4  
Age, Customized  
[units: participants]
 		     
18-44 years     8     7     15  
45-64 years     121     151     272  
>=65 years     90     80     170  
Gender  
[units: participants]
 		     
Female     72     72     144  
Male     147     166     313  
Race/Ethnicity, Customized  
[units: participants]
 		     
Black     6     4     10  
White     213     234     447  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Lung Function as Measured by the Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0-3h (AUC0-3h)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 1

2.  Secondary:   Trough Forced Expiratory Volume in 1 Second (FEV1)(Baseline)   [ Time Frame: Baseline ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 8)   [ Time Frame: Baseline, week 8 ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 16)   [ Time Frame: Baseline, week 16 ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Trough Forced Expiratory Volume in 1 Second (at Week 24)   [ Time Frame: Baseline, week 24 ]
  Show Outcome Measure 5

6.  Secondary:   Peak Forced Expiratory Volume in 1 Second (Baseline)   [ Time Frame: Baseline ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 8)   [ Time Frame: Baseline, week 8 ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16)   [ Time Frame: Baseline, week 16 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24)   [ Time Frame: Baseline, week 24 ]
  Show Outcome Measure 9

10.  Secondary:   Forced Expiratory Volume in 1 Second (Baseline, Pre-dose)   [ Time Frame: Baseline ]
  Show Outcome Measure 10

11.  Secondary:   Forced Expiratory Volume in 1 Second (Baseline, 30 Minutes)   [ Time Frame: baseline, 30 minutes ]
  Show Outcome Measure 11

12.  Secondary:   Forced Expiratory Volume in 1 Second (Baseline, 60 Minutes)   [ Time Frame: baseline, 60 minutes ]
  Show Outcome Measure 12

13.  Secondary:   Forced Expiratory Volume in 1 Second (Baseline, 120 Minutes)   [ Time Frame: Baseline, 120 minutes ]
  Show Outcome Measure 13

14.  Secondary:   Forced Expiratory Volume in 1 Second (Baseline, 180 Minutes)   [ Time Frame: Baseline, 180 minutes ]
  Show Outcome Measure 14

15.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, Pre-dose)   [ Time Frame: baseline, week 8, pre-dose ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 30 Minutes)   [ Time Frame: Baseline, week 8, 30 minutes ]
  Show Outcome Measure 16

17.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 60 Minutes)   [ Time Frame: baseline, week 8, 60 minutes ]
  Show Outcome Measure 17

18.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 120 Minutes)   [ Time Frame: baseline, week 8, 120 minutes ]
  Show Outcome Measure 18

19.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 8, 180 Minutes)   [ Time Frame: baseline, week 8, 180 minutes ]
  Show Outcome Measure 19

20.  Secondary:   Change From Baseline in Forced Expiratory Volume in 1 Second (at Week 16, Pre-dose)   [ Time Frame: baseline, week 16, pre-dose ]
  Show Outcome Measure 20

21.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 30 Minutes)   [ Time Frame: Baseline, week 16, 30 minutes ]
  Show Outcome Measure 21

22.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 60 Minutes)   [ Time Frame: baseline, week 16, 60 minutes ]
  Show Outcome Measure 22

23.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 120 Minutes)   [ Time Frame: baseline, week 16, 120 minutes ]
  Show Outcome Measure 23

24.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 16, 180 Minutes)   [ Time Frame: baseline, week 16, 180 minutes ]
  Show Outcome Measure 24

25.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, Pre-dose)   [ Time Frame: baseline, week 24, pre-dose ]
  Show Outcome Measure 25

26.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 30 Minutes)   [ Time Frame: baseline, week 24, 30 minutes ]
  Show Outcome Measure 26

27.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 60 Minutes)   [ Time Frame: baseline, week 24, 60 minutes ]
  Show Outcome Measure 27

28.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 120 Minutes)   [ Time Frame: baseline, week 24, 120 minutes ]
  Show Outcome Measure 28

29.  Secondary:   Change From Baseline in Peak Forced Expiratory Volume in 1 Second (at Week 24, 180 Minutes)   [ Time Frame: baseline, week 24, 180 minutes ]
  Show Outcome Measure 29

30.  Secondary:   Forced Vital Capacity (FVC) Area Under the Curve From 0-3 Hours (AUC0-3h)   [ Time Frame: baseline ]
  Show Outcome Measure 30

31.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC) Area Under the Curve From 0-3 Hours (AUC0-3h) (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 31

32.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC) Area Under the Curve From 0-3 Hours (AUC0-3h)(Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 32

33.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC) Area Under the Curve From 0-3 Hours (AUC0-3h) (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 33

34.  Secondary:   Trough Forced Vital Capacity (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 34

35.  Secondary:   Change From Baseline in Trough Forced Vital Capacity (at Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 35

36.  Secondary:   Change From Baseline in Trough Forced Vital Capacity (at Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 36

37.  Secondary:   Change From Baseline in Trough Forced Vital Capacity (at Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 37

38.  Secondary:   Peak Forced Vital Capacity (FVC) (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 38

39.  Secondary:   Change From Baseline in Peak Forced Vital Capacity (at Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 39

40.  Secondary:   Change From Baseline in Peak Forced Vital Capacity (at Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 40

41.  Secondary:   Change From Baseline in Peak Forced Vital Capacity (at Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 41

42.  Secondary:   Forced Vital Capacity (Baseline, Pre-dose)   [ Time Frame: baseline ]
  Show Outcome Measure 42

43.  Secondary:   Forced Vital Capacity (Baseline, 30 Minutes)   [ Time Frame: baseline, 30 minutes ]
  Show Outcome Measure 43

44.  Secondary:   Forced Vital Capacity (Baseline, 60 Minutes)   [ Time Frame: baseline, 60 minutes ]
  Show Outcome Measure 44

45.  Secondary:   Forced Vital Capacity (Baseline, 120 Minutes)   [ Time Frame: baseline, 120 minutes ]
  Show Outcome Measure 45

46.  Secondary:   Forced Vital Capacity (Baseline, 180 Minutes)   [ Time Frame: baseline, 180 minutes ]
  Show Outcome Measure 46

47.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 8, Pre-dose)   [ Time Frame: baseline, week 8, pre-dose ]
  Show Outcome Measure 47

48.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 8, 30 Minutes)   [ Time Frame: baseline, week 8, 30 minutes ]
  Show Outcome Measure 48

49.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 8, 60 Minutes)   [ Time Frame: baseline, week 8, 60 minutes ]
  Show Outcome Measure 49

50.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 8, 120 Minutes)   [ Time Frame: baseline, week 8, 120 minutes ]
  Show Outcome Measure 50

51.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 8, 180 Minutes)   [ Time Frame: baseline, week 8, 180 minutes ]
  Show Outcome Measure 51

52.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 16, Pre-dose)   [ Time Frame: baseline, week 16, pre-dose ]
  Show Outcome Measure 52

53.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 16, 30 Minutes)   [ Time Frame: baseline, week 16, 30 minutes ]
  Show Outcome Measure 53

54.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 16, 60 Minutes)   [ Time Frame: baseline, week 16, 60 minutes ]
  Show Outcome Measure 54

55.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 16, 120 Minutes)   [ Time Frame: baseline, week 16, 120 minutes ]
  Show Outcome Measure 55

56.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 16, 180 Minutes)   [ Time Frame: baseline, week 16, 180 minutes ]
  Show Outcome Measure 56

57.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 24, Pre-dose)   [ Time Frame: baseline, week 24, pre-dose ]
  Show Outcome Measure 57

58.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 24, 30 Minutes)   [ Time Frame: baseline, week 24, 30 minutes ]
  Show Outcome Measure 58

59.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 24, 60 Minutes)   [ Time Frame: baseline, week 24, 60 minutes ]
  Show Outcome Measure 59

60.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 24, 120 Minutes)   [ Time Frame: baseline, week 24, 120 minutes ]
  Show Outcome Measure 60

61.  Secondary:   Change From Baseline in Forced Vital Capacity (Week 24, 180 Minutes)   [ Time Frame: baseline, week 24, 180 minutes ]
  Show Outcome Measure 61

62.  Secondary:   Albuterol Use p.r.n. (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 62

63.  Secondary:   Change From Baseline in Albuterol Use p.r.n. - (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 63

64.  Secondary:   Change From Baseline in Albuterol Use p.r.n. - (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 64

65.  Secondary:   Change From Baseline in Albuterol Use p.r.n. -(Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 65

66.  Secondary:   Change From Baseline in Albuterol Use p.r.n. - (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 66

67.  Secondary:   Change From Baseline in Albuterol Use p.r.n. -(Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 67

68.  Secondary:   Change From Baseline in Albuterol Use p.r.n. - (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 68

69.  Secondary:   Number of Participants With Categorical Scores on Physician's Global Assessment (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 69

70.  Secondary:   Number of Participants With Categorical Scores on Physician's Global Assessment (Week 12)   [ Time Frame: week 12 ]
  Show Outcome Measure 70

71.  Secondary:   Number of Participants With Categorical Scores on Physician's Global Assessment (Week 24)   [ Time Frame: week 24 ]
  Show Outcome Measure 71

72.  Secondary:   Number of Participants With Categorical Scores on Patient's Global Assessment (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 72

73.  Secondary:   Number of Participants With Categorical Scores on Patient's Global Assessment (Week 12)   [ Time Frame: week 12 ]
  Show Outcome Measure 73

74.  Secondary:   Number of Participants With Categorical Scores on Patient's Global Assessment (Week 24)   [ Time Frame: week 24 ]
  Show Outcome Measure 74

75.  Secondary:   Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 75

76.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 76

77.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 77

78.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 78

79.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 79

80.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 80

81.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment Due to Health (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 81

82.  Secondary:   Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health   [ Time Frame: baseline ]
  Show Outcome Measure 82

83.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 83

84.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 84

85.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 85

86.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 86

87.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 87

88.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Impairment While Working Due to Health (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 88

89.  Secondary:   Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 89

90.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 90

91.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 91

92.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 92

93.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 93

94.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 94

95.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Overall Work Impairment Due to Health (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 95

96.  Secondary:   Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 96

97.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 97

98.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 98

99.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 99

100.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 100

101.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 101

102.  Secondary:   Change From Baseline in Work Productivity as Assessed by the Work Productivity and Activity Impairment (WPAI) Questionnaire: Work Time Missed Due to Health (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 102

103.  Secondary:   Physical Activity (Light Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline ]
  Show Outcome Measure 103

104.  Secondary:   Change From Baseline in Physical Activity (Light Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 104

105.  Secondary:   Change From Baseline in Physical Activity (Light Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 105

106.  Secondary:   Change From Baseline in Physical Activity (Light Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 106

107.  Secondary:   Change From Baseline in Physical Activity (Light Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 107

108.  Secondary:   Change From Baseline in Physical Activity (Light Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 108

109.  Secondary:   Change From Baseline in Physical Activity (Light Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 109

110.  Secondary:   Physical Activity (Moderate or Higher Intensity; Baseline) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline ]
  Show Outcome Measure 110

111.  Secondary:   Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 4) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 111

112.  Secondary:   Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 8) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 112

113.  Secondary:   Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 12) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 113

114.  Secondary:   Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 16) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 114

115.  Secondary:   Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 20) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 115

116.  Secondary:   Change From Baseline in Physical Activity (Moderate or Higher Intensity; Week 24) in Logarithm of Average Time Spent in Minutes Per Day   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 116

117.  Secondary:   Number of Participants With Healthy Lifestyle (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 117

118.  Secondary:   Number of Participants With Healthy Lifestyle (Week 4)   [ Time Frame: week 4 ]
  Show Outcome Measure 118

119.  Secondary:   Number of Participants With Healthy Lifestyle (Week 8)   [ Time Frame: week 8 ]
  Show Outcome Measure 119

120.  Secondary:   Number of Participants With Healthy Lifestyle (Week 12)   [ Time Frame: week 12 ]
  Show Outcome Measure 120

121.  Secondary:   Number of Participants With Healthy Lifestyle (Week 16)   [ Time Frame: week 16 ]
  Show Outcome Measure 121

122.  Secondary:   Number of Participants With Healthy Lifestyle (Week 20)   [ Time Frame: week 20 ]
  Show Outcome Measure 122

123.  Secondary:   Number of Participants With Healthy Lifestyle (Week 24)   [ Time Frame: week 24 ]
  Show Outcome Measure 123

124.  Secondary:   Active Energy Expenditure (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 124

125.  Secondary:   Change From Baseline in Active Energy Expenditure (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 125

126.  Secondary:   Change From Baseline in Active Energy Expenditure (Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 126

127.  Secondary:   Change From Baseline in Active Energy Expenditure (Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 127

128.  Secondary:   Change From Baseline in Active Energy Expenditure (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 128

129.  Secondary:   Change From Baseline in Active Energy Expenditure (Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 129

130.  Secondary:   Change From Baseline in Active Energy Expenditure (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 130

131.  Secondary:   Number of Steps Per Day (Baseline)   [ Time Frame: baseline ]
  Show Outcome Measure 131

132.  Secondary:   Change From Baseline in Number of Steps Per Day (Week 4)   [ Time Frame: baseline, week 4 ]
  Show Outcome Measure 132

133.  Secondary:   Change From Baseline in Number of Steps Per Day(Week 8)   [ Time Frame: baseline, week 8 ]
  Show Outcome Measure 133

134.  Secondary:   Change From Baseline in Number of Steps Per Day (Week 12)   [ Time Frame: baseline, week 12 ]
  Show Outcome Measure 134

135.  Secondary:   Change From Baseline in Number of Steps Per Day (Week 16)   [ Time Frame: baseline, week 16 ]
  Show Outcome Measure 135

136.  Secondary:   Change From Baseline in Number of Steps Per Day (Week 20)   [ Time Frame: baseline, week 20 ]
  Show Outcome Measure 136

137.  Secondary:   Change From Baseline in Number of Steps Per Day (Week 24)   [ Time Frame: baseline, week 24 ]
  Show Outcome Measure 137


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
For individual outcome measures, only timepoints that had data collected are presented here.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00523991     History of Changes
Obsolete Identifiers: NCT00460772
Other Study ID Numbers: 205.365, A4471008, 2006-006276-38
Study First Received: July 9, 2007
Results First Received: July 1, 2011
Last Updated: November 25, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products;   Canada: Health Canada - Therapeutic Products Directorate;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Greece: National Organization of Medicines (EOF);   Netherlands: Central Committee on Research involving Human Subjects (CCMO);   Portugal: National Pharmacy and Medicines Institute;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration





Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services