Assessment of Health-status of Patients With Chronic Obstructive Pulmonary Disease (COPD) on Maintenance Therapy With Spiriva HH Measured by COPD Assessment Test (CAT) Test
MATHS: Assessment of Health-status of Patients With COPD on MAintenance THerapy With Spiriva® HH Measured by CAT Test
1 other identifier
interventional
1,328
1 country
247
Brief Summary
To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2011
247 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 17, 2012
CompletedFirst Posted
Study publicly available on registry
July 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
May 26, 2014
CompletedMay 26, 2014
April 1, 2014
1.3 years
July 17, 2012
March 28, 2014
April 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients Maintaining or Improving Their Health Status
The health status was measured by the total COPD Assessment Test (CAT) score at baseline and at the end of the observation period after app. 3 months (visit 3). Therefore, the total CAT score at baseline and at Visit 3 was calculated by adding up the scores of the single questions of the CAT questionnaire. In the case of one or more missing items the total score was not determined for the specific visit. The health status is considered to be maintained or improved if the change in the total CAT score from baseline at Visit 3 is ≥0.
Baseline, 3 months
Secondary Outcomes (1)
Change in the Total CAT Score (Value Baseline Minus 3 Months)
Baseline, 3 months
Interventions
Eligibility Criteria
You may qualify if:
- Male and female ambulatory outpatients being seen in a participating physicians office for routine care,
- Patients with a clinical diagnosis of COPD (all stages according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2010) being treated with long-acting anticholinergic (Tiotropium, Spiriva® HandiHaler® ) as maintenance therapy within the product label and a maximum of the last 4 weeks (0.-28. days before Visit 1),
- Patients previously treated with short-acting bronchodilators on regular or as-needed basis for at least 3 months before change to long-acting anticholinergic treatment,
- Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone.
You may not qualify if:
- Uncooperative patients as judged by the physician,
- Patients with any conditions excluded as per Country specific package insert,
- Patients currently enrolled in any clinical trial,
- Patients with COPD exacerbation or any acute disease in the last 3 months before Visit 1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Pfizercollaborator
Study Sites (247)
Boehringer Ingelheim Investigational Site 236
Andrychów, Poland
Boehringer Ingelheim Investigational Site 170
Bialystok, Poland
Boehringer Ingelheim Investigational Site 184
Bialystok, Poland
Boehringer Ingelheim Investigational Site 240
Bialystok, Poland
Boehringer Ingelheim Investigational Site 44
Bialystok, Poland
Boehringer Ingelheim Investigational Site 84
Bialystok, Poland
Boehringer Ingelheim Investigational Site 33
Bielsko-Biala, Poland
Boehringer Ingelheim Investigational Site 34
Bielsko-Biala, Poland
Boehringer Ingelheim Investigational Site 35
Bielsko-Biala, Poland
Boehringer Ingelheim Investigational Site 79
Biskupiec, Poland
Boehringer Ingelheim Investigational Site 116
Bochnia, Poland
Boehringer Ingelheim Investigational Site 115
Brzesko, Poland
Boehringer Ingelheim Investigational Site 138
Brzesko, Poland
Boehringer Ingelheim Investigational Site 185
Brzeziny, Poland
Boehringer Ingelheim Investigational Site 90
Brzozów, Poland
Boehringer Ingelheim Investigational Site 105
Bydgoszcz, Poland
Boehringer Ingelheim Investigational Site 119
Bydgoszcz, Poland
Boehringer Ingelheim Investigational Site 123
Bydgoszcz, Poland
Boehringer Ingelheim Investigational Site 222
Bydgoszcz, Poland
Boehringer Ingelheim Investigational Site 27
Bydgoszcz, Poland
Boehringer Ingelheim Investigational Site 21
Chełm, Poland
Boehringer Ingelheim Investigational Site 22
Chełm, Poland
Boehringer Ingelheim Investigational Site 11
Chełmsko Śląskie, Poland
Boehringer Ingelheim Investigational Site 233
Chodzież, Poland
Boehringer Ingelheim Investigational Site 226
Chojnice, Poland
Boehringer Ingelheim Investigational Site 149
Chorzów, Poland
Boehringer Ingelheim Investigational Site 153
Chorzów, Poland
Boehringer Ingelheim Investigational Site 88
Ciechanów, Poland
Boehringer Ingelheim Investigational Site 232
Czarnków, Poland
Boehringer Ingelheim Investigational Site 229
Częstochowa, Poland
Boehringer Ingelheim Investigational Site 4
Częstochowa, Poland
Boehringer Ingelheim Investigational Site 23
Dąbrowa Górnicza, Poland
Boehringer Ingelheim Investigational Site 92
Domaradz, Poland
Boehringer Ingelheim Investigational Site 246
Dziergowice, Poland
Boehringer Ingelheim Investigational Site 133
Gdansk, Poland
Boehringer Ingelheim Investigational Site 134
Gdansk, Poland
Boehringer Ingelheim Investigational Site 136
Gdansk, Poland
Boehringer Ingelheim Investigational Site 155
Gdansk, Poland
Boehringer Ingelheim Investigational Site 156
Gdansk, Poland
Boehringer Ingelheim Investigational Site 20
Gdansk, Poland
Boehringer Ingelheim Investigational Site 234
Gdansk, Poland
Boehringer Ingelheim Investigational Site 31
Gdansk, Poland
Boehringer Ingelheim Investigational Site 41
Gdynia, Poland
Boehringer Ingelheim Investigational Site 217
Gliwice, Poland
Boehringer Ingelheim Investigational Site 243
Gmina Jędrzejów, Poland
Boehringer Ingelheim Investigational Site 141
Gmina Końskie, Poland
Boehringer Ingelheim Investigational Site 142
Gmina Końskie, Poland
Boehringer Ingelheim Investigational Site 73
Gmina Sawin, Poland
Boehringer Ingelheim Investigational Site 107
Gmina Śrem, Poland
Boehringer Ingelheim Investigational Site 213
Gmina Śrem, Poland
Boehringer Ingelheim Investigational Site 181
Gmina Świecie, Poland
Boehringer Ingelheim Investigational Site 38
Gmina Uchanie, Poland
Boehringer Ingelheim Investigational Site 50
Gorzów Wielkopolski, Poland
Boehringer Ingelheim Investigational Site 85
Góra, Poland
Boehringer Ingelheim Investigational Site 174
Grodzisk Mazowiecki, Poland
Boehringer Ingelheim Investigational Site 176
Grodzisk Mazowiecki, Poland
Boehringer Ingelheim Investigational Site 56
Gryfice, Poland
Boehringer Ingelheim Investigational Site 247
Głuchołazy, Poland
Boehringer Ingelheim Investigational Site 179
Jarosław, Poland
Boehringer Ingelheim Investigational Site 108
Jasło, Poland
Boehringer Ingelheim Investigational Site 225
Jasło, Poland
Boehringer Ingelheim Investigational Site 8
Jasło, Poland
Boehringer Ingelheim Investigational Site 148
Jelenia Góra, Poland
Boehringer Ingelheim Investigational Site 162
Katowice, Poland
Boehringer Ingelheim Investigational Site 163
Katowice, Poland
Boehringer Ingelheim Investigational Site 164
Katowice, Poland
Boehringer Ingelheim Investigational Site 212
Katowice, Poland
Boehringer Ingelheim Investigational Site 69
Kcynia, Poland
Boehringer Ingelheim Investigational Site 112
Kielce, Poland
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Kielce, Poland
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Kielce, Poland
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Konin, Poland
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Koszalin, Poland
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Koszalin, Poland
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Kołobrzeg, Poland
Boehringer Ingelheim Investigational Site 122
Krakow, Poland
Boehringer Ingelheim Investigational Site 135
Krakow, Poland
Boehringer Ingelheim Investigational Site 143
Krakow, Poland
Boehringer Ingelheim Investigational Site 146
Krakow, Poland
Boehringer Ingelheim Investigational Site 171
Krakow, Poland
Boehringer Ingelheim Investigational Site 177
Krakow, Poland
Boehringer Ingelheim Investigational Site 214
Krakow, Poland
Boehringer Ingelheim Investigational Site 87
Krakow, Poland
Boehringer Ingelheim Investigational Site 94
Krakow, Poland
Boehringer Ingelheim Investigational Site 129
Kraśnik, Poland
Boehringer Ingelheim Investigational Site 204
Kraśnik, Poland
Boehringer Ingelheim Investigational Site 207
Kraśnik, Poland
Boehringer Ingelheim Investigational Site 192
Krosno, Poland
Boehringer Ingelheim Investigational Site 194
Kutno, Poland
Boehringer Ingelheim Investigational Site 13
Kłodzko, Poland
Boehringer Ingelheim Investigational Site 97
Legionowo, Poland
Boehringer Ingelheim Investigational Site 86
Lędziny, Poland
Boehringer Ingelheim Investigational Site 127
Liśnik Duży, Poland
Boehringer Ingelheim Investigational Site 187
Lodz, Poland
Boehringer Ingelheim Investigational Site 188
Lodz, Poland
Boehringer Ingelheim Investigational Site 193
Lodz, Poland
Boehringer Ingelheim Investigational Site 198
Lodz, Poland
Boehringer Ingelheim Investigational Site 206
Lodz, Poland
Boehringer Ingelheim Investigational Site 186
Lowicz, Poland
Boehringer Ingelheim Investigational Site 158
Lubań, Poland
Boehringer Ingelheim Investigational Site 37
Lubartów, Poland
Boehringer Ingelheim Investigational Site 172
Lubin, Poland
Boehringer Ingelheim Investigational Site 173
Lubin, Poland
Boehringer Ingelheim Investigational Site 196
Lubin, Poland
Boehringer Ingelheim Investigational Site 124
Lublin, Poland
Boehringer Ingelheim Investigational Site 17
Lublin, Poland
Boehringer Ingelheim Investigational Site 29
Lublin, Poland
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Lublin, Poland
Boehringer Ingelheim Investigational Site 242
Lubliniec, Poland
Boehringer Ingelheim Investigational Site 209
Luboń, Poland
Boehringer Ingelheim Investigational Site 106
Ludwikowo, Poland
Boehringer Ingelheim Investigational Site 45
Maków Mazowiecki, Poland
Boehringer Ingelheim Investigational Site 168
Malbork, Poland
Boehringer Ingelheim Investigational Site 110
Mielec, Poland
Boehringer Ingelheim Investigational Site 159
Milicz, Poland
Boehringer Ingelheim Investigational Site 25
Myszków, Poland
Boehringer Ingelheim Investigational Site 150
Mysłowice, Poland
Boehringer Ingelheim Investigational Site 215
Nisko, Poland
Boehringer Ingelheim Investigational Site 128
Nowy Dwór Gdański, Poland
Boehringer Ingelheim Investigational Site 109
Nowy Sącz, Poland
Boehringer Ingelheim Investigational Site 72
Olecko, Poland
Boehringer Ingelheim Investigational Site 36
Olsztyn, Poland
Boehringer Ingelheim Investigational Site 245
Opatów, Poland
Boehringer Ingelheim Investigational Site 114
Ostrowiec Świętokrzyski, Poland
Boehringer Ingelheim Investigational Site 145
Ostrowiec Świętokrzyski, Poland
Boehringer Ingelheim Investigational Site 154
Oława, Poland
Boehringer Ingelheim Investigational Site 237
Pabianice, Poland
Boehringer Ingelheim Investigational Site 182
Papowo Biskupie, Poland
Boehringer Ingelheim Investigational Site 216
Pawonków, Poland
Boehringer Ingelheim Investigational Site 189
Piekary Śląskie, Poland
Boehringer Ingelheim Investigational Site 32
Pietrzykowice, Poland
Boehringer Ingelheim Investigational Site 203
Piotrkow Trybunalski, Poland
Boehringer Ingelheim Investigational Site 40
Piła, Poland
Boehringer Ingelheim Investigational Site 93
Pniewy, Poland
Boehringer Ingelheim Investigational Site 130
Poniatowa, Poland
Boehringer Ingelheim Investigational Site 201
Poznan, Poland
Boehringer Ingelheim Investigational Site 208
Poznan, Poland
Boehringer Ingelheim Investigational Site 227
Poznan, Poland
Boehringer Ingelheim Investigational Site 228
Poznan, Poland
Boehringer Ingelheim Investigational Site 231
Poznan, Poland
Boehringer Ingelheim Investigational Site 126
Prabuty, Poland
Boehringer Ingelheim Investigational Site 218
Proszowice, Poland
Boehringer Ingelheim Investigational Site 131
Pruszcz Gdański, Poland
Boehringer Ingelheim Investigational Site 191
Przemyśl, Poland
Boehringer Ingelheim Investigational Site 59
Płock, Poland
Boehringer Ingelheim Investigational Site 169
Rabka-Zdrój, Poland
Boehringer Ingelheim Investigational Site 117
Radom, Poland
Boehringer Ingelheim Investigational Site 118
Radom, Poland
Boehringer Ingelheim Investigational Site 151
Ruda Śląska, Poland
Boehringer Ingelheim Investigational Site 152
Ruda Śląska, Poland
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Ruda Śląska, Poland
Boehringer Ingelheim Investigational Site 82
Ruda Śląska, Poland
Boehringer Ingelheim Investigational Site 180
Rumia, Poland
Boehringer Ingelheim Investigational Site 239
Rumia, Poland
Boehringer Ingelheim Investigational Site 5
Rumia, Poland
Boehringer Ingelheim Investigational Site 104
Rybnik, Poland
Boehringer Ingelheim Investigational Site 183
Rybnik, Poland
Boehringer Ingelheim Investigational Site 83
Rybnik, Poland
Boehringer Ingelheim Investigational Site 175
Rzeszów, Poland
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Rzeszów, Poland
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Sanok, Poland
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Sejny, Poland
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Siewierz, Poland
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Skarżysko-Kamienna, Poland
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Skawina, Poland
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Skoczów, Poland
Boehringer Ingelheim Investigational Site 167
Skrzyszów, Poland
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Sokołowsko, Poland
Boehringer Ingelheim Investigational Site 113
Sopot, Poland
Boehringer Ingelheim Investigational Site 166
Sosnowiec, Poland
Boehringer Ingelheim Investigational Site 24
Sosnowiec, Poland
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Stalowa Wola, Poland
Boehringer Ingelheim Investigational Site 144
Starachowice, Poland
Boehringer Ingelheim Investigational Site 80
Starachowice, Poland
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Stargard, Poland
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Sucha Beskidzka, Poland
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Supraśl, Poland
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Suwałki, Poland
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Suwałki, Poland
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Syców, Poland
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Szczecin, Poland
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Szczecin, Poland
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Szczecin, Poland
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Szczecin, Poland
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Szczecin, Poland
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Szczecinek, Poland
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Sławno, Poland
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Słubice, Poland
Boehringer Ingelheim Investigational Site 205
Słupca, Poland
Boehringer Ingelheim Investigational Site 1
Świdnik, Poland
Boehringer Ingelheim Investigational Site 111
Tarnobrzeg, Poland
Boehringer Ingelheim Investigational Site 224
Tarnobrzeg, Poland
Boehringer Ingelheim Investigational Site 200
Tarnowskie Góry, Poland
Boehringer Ingelheim Investigational Site 139
Tarnów, Poland
Boehringer Ingelheim Investigational Site 140
Tarnów, Poland
Boehringer Ingelheim Investigational Site 101
Torun, Poland
Boehringer Ingelheim Investigational Site 70
Torun, Poland
Boehringer Ingelheim Investigational Site 71
Torun, Poland
Boehringer Ingelheim Investigational Site 220
Trzcianka Lubuska, Poland
Boehringer Ingelheim Investigational Site 103
Twardogóra, Poland
Boehringer Ingelheim Investigational Site 147
Tychy, Poland
Boehringer Ingelheim Investigational Site 244
Tychy, Poland
Boehringer Ingelheim Investigational Site 100
Warsaw, Poland
Boehringer Ingelheim Investigational Site 121
Warsaw, Poland
Boehringer Ingelheim Investigational Site 137
Warsaw, Poland
Boehringer Ingelheim Investigational Site 161
Warsaw, Poland
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Warsaw, Poland
Boehringer Ingelheim Investigational Site 210
Warsaw, Poland
Boehringer Ingelheim Investigational Site 223
Warsaw, Poland
Boehringer Ingelheim Investigational Site 238
Warsaw, Poland
Boehringer Ingelheim Investigational Site 2
Warsaw, Poland
Boehringer Ingelheim Investigational Site 3
Warsaw, Poland
Boehringer Ingelheim Investigational Site 42
Warsaw, Poland
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Warsaw, Poland
Boehringer Ingelheim Investigational Site 74
Warsaw, Poland
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Warsaw, Poland
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Warsaw, Poland
Boehringer Ingelheim Investigational Site 39
Wałcz, Poland
Boehringer Ingelheim Investigational Site 6
Wejherowo, Poland
Boehringer Ingelheim Investigational Site 199
Wieliczna, Poland
Boehringer Ingelheim Investigational Site 235
Wieluń, Poland
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Witonia, Poland
Boehringer Ingelheim Investigational Site 65
Wloc³awek, Poland
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Wodzisław Śląski, Poland
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Wołomin, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Wroclaw, Poland
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Zabrze, Poland
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Zabrze, Poland
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Zabrze, Poland
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Ząbkowice Śląskie, Poland
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Ząbkowice Śląskie, Poland
Boehringer Ingelheim Investigational Site 60
Zągoty, Poland
Boehringer Ingelheim Investigational Site 132
Zblewo, Poland
Boehringer Ingelheim Investigational Site 195
Zgierz, Poland
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Zielona Góra, Poland
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Zielona Góra, Poland
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Zielonka k/Warszawy, Poland
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Żyrardów, Poland
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Łomża, Poland
Boehringer Ingelheim Investigational Site 58
Łomża, Poland
Boehringer Ingelheim Investigational Site 30
Łuków, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim Pharmaceuticals
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2012
First Posted
July 19, 2012
Study Start
November 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
May 26, 2014
Results First Posted
May 26, 2014
Record last verified: 2014-04