Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01353274
First received: May 9, 2011
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension


Condition Intervention
Hypertension
Drug: Micamlo

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Incidence of Drug-related Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients with drug-related adverse events


Secondary Outcome Measures:
  • Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: after 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Change from baseline in SBP after 1, 2, 3, 6, 12 months

  • Change From Baseline in Diastolic Blood Pressure (DBP) [ Time Frame: after 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Change from baseline in DBP after 1, 2, 3, 6, 12 months

  • Proportion of Patients Who Achieved the Target BP [ Time Frame: after 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months

  • Proportion of Patients Who Normalised Their BP [ Time Frame: after 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months


Enrollment: 1157
Study Start Date: May 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with hypertension Drug: Micamlo
Telmisartan plus Amlodipine T40/A5

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

1200

Criteria

Inclusion criteria:

- Male and Female patients with hypertension who did not receive of MICAMLO Combination Tablets AP before the start of the study

Exclusion criteria:

  • Patients with a history of hypersensitivity to any ingredient of Micamlo Combination Tablets AP and dihydropyridine derivatives
  • Pregnant woman or possibly pregnant woman
  • Patients with extremely poor bile secretion or patients with serious hepatic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353274

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Locations
Japan
Boehringer Ingelheim Investigational Site 199
Akaiwa, Japan
Boehringer Ingelheim Investigational Site 83
Akishima, Japan
Boehringer Ingelheim Investigational Site 25
Akita, Japan
Boehringer Ingelheim Investigational Site 188
Amagasaki, Japan
Boehringer Ingelheim Investigational Site 116
Anamizu-machi, Japan
Boehringer Ingelheim Investigational Site 212
Anan, Japan
Boehringer Ingelheim Investigational Site 145
Anjo, Japan
Boehringer Ingelheim Investigational Site 11
Aomori, Japan
Boehringer Ingelheim Investigational Site 12
Aomori, Japan
Boehringer Ingelheim Investigational Site 192
Arita, Japan
Boehringer Ingelheim Investigational Site 7
Asahikawa, Japan
Boehringer Ingelheim Investigational Site 104
Atsugi, Japan
Boehringer Ingelheim Investigational Site 58
Chiba, Japan
Boehringer Ingelheim Investigational Site 57
Chiba, Japan
Boehringer Ingelheim Investigational Site 232
Chikuzen-machi, Japan
Boehringer Ingelheim Investigational Site 143
Chita, Japan
Boehringer Ingelheim Investigational Site 24
Daisen, Japan
Boehringer Ingelheim Investigational Site 23
Daisen, Japan
Boehringer Ingelheim Investigational Site 10
Date, Japan
Boehringer Ingelheim Investigational Site 90
Fuchu, Japan
Boehringer Ingelheim Investigational Site 52
Fujimino, Japan
Boehringer Ingelheim Investigational Site 129
Fujinomiya, Japan
Boehringer Ingelheim Investigational Site 103
Fujisawa, Japan
Boehringer Ingelheim Investigational Site 158
Fukuchiyama, Japan
Boehringer Ingelheim Investigational Site 225
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 224
Fukuoka, Japan
Boehringer Ingelheim Investigational Site 29
Fukushima, Japan
Boehringer Ingelheim Investigational Site 13
Hachinohe, Japan
Boehringer Ingelheim Investigational Site 130
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 131
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site 219
Handa, Japan
Boehringer Ingelheim Investigational Site 171
Hannan, Japan
Boehringer Ingelheim Investigational Site 204
Hatsukaichi, Japan
Boehringer Ingelheim Investigational Site 208
Higashihiroshima, Japan
Boehringer Ingelheim Investigational Site 5
Higashikagura-cho, Japan
Boehringer Ingelheim Investigational Site 66
Higashimurayama, Japan
Boehringer Ingelheim Investigational Site 151
Hikone, Japan
Boehringer Ingelheim Investigational Site 179
Himeji, Japan
Boehringer Ingelheim Investigational Site 181
Himeji, Japan
Boehringer Ingelheim Investigational Site 180
Himeji, Japan
Boehringer Ingelheim Investigational Site 169
Hirakata, Japan
Boehringer Ingelheim Investigational Site 170
Hirakata, Japan
Boehringer Ingelheim Investigational Site 203
Hiroshima, Japan
Boehringer Ingelheim Investigational Site 201
Hiroshima, Japan
Boehringer Ingelheim Investigational Site 202
Hiroshima, Japan
Boehringer Ingelheim Investigational Site 38
Hitachinaka, Japan
Boehringer Ingelheim Investigational Site 37
Hitachiota, Japan
Boehringer Ingelheim Investigational Site 62
Ichikawa, Japan
Boehringer Ingelheim Investigational Site 17
Ichinoseki, Japan
Boehringer Ingelheim Investigational Site 223
Iizuka, Japan
Boehringer Ingelheim Investigational Site 175
Ikeda, Japan
Boehringer Ingelheim Investigational Site 238
Iki, Japan
Boehringer Ingelheim Investigational Site 63
IKisarazu, Japan
Boehringer Ingelheim Investigational Site 191
Ikoma, Japan
Boehringer Ingelheim Investigational Site 111
Imizu, Japan
Boehringer Ingelheim Investigational Site 189
Itami, Japan
Boehringer Ingelheim Investigational Site 253
Itoman, Japan
Boehringer Ingelheim Investigational Site 233
Itoshima, Japan
Boehringer Ingelheim Investigational Site 252
Izumi, Japan
Boehringer Ingelheim Investigational Site 125
Kagamihara, Japan
Boehringer Ingelheim Investigational Site 250
Kagoshima, Japan
Boehringer Ingelheim Investigational Site 249
Kagoshima, Japan
Boehringer Ingelheim Investigational Site 229
Kama, Japan
Boehringer Ingelheim Investigational Site 152
Kameoka, Japan
Boehringer Ingelheim Investigational Site 241
Kamiamakusa, Japan
Boehringer Ingelheim Investigational Site 242
Kamiamakusa, Japan
Boehringer Ingelheim Investigational Site 22
Kamimachi, Japan
Boehringer Ingelheim Investigational Site 113
Kanazawa, Japan
Boehringer Ingelheim Investigational Site 114
Kanazawa, Japan
Boehringer Ingelheim Investigational Site 237
Kanzaki, Japan
Boehringer Ingelheim Investigational Site 144
Kariya, Japan
Boehringer Ingelheim Investigational Site 34
Kasama, Japan
Boehringer Ingelheim Investigational Site 33
Kasama, Japan
Boehringer Ingelheim Investigational Site 138
Kasugai, Japan
Boehringer Ingelheim Investigational Site 137
Kasugai, Japan
Boehringer Ingelheim Investigational Site 48
Kasukabe, Japan
Boehringer Ingelheim Investigational Site 49
Kasukabe, Japan
Boehringer Ingelheim Investigational Site 178
Kato, Japan
Boehringer Ingelheim Investigational Site 177
Kato, Japan
Boehringer Ingelheim Investigational Site 117
Katsuyama, Japan
Boehringer Ingelheim Investigational Site 121
Kawachinagano, Japan
Boehringer Ingelheim Investigational Site 51
Kawaguchi, Japan
Boehringer Ingelheim Investigational Site 100
Kawasaki, Japan
Boehringer Ingelheim Investigational Site 101
Kawasaki, Japan
Boehringer Ingelheim Investigational Site 43
Kiryu, Japan
Boehringer Ingelheim Investigational Site 176
Kita-ku, Japan
Boehringer Ingelheim Investigational Site 15
Kitakami, Japan
Boehringer Ingelheim Investigational Site 226
Kitakyushu, Japan
Boehringer Ingelheim Investigational Site 227
Kitakyushu, Japan
Boehringer Ingelheim Investigational Site 4
Kitami, Japan
Boehringer Ingelheim Investigational Site 186
Kobe, Japan
Boehringer Ingelheim Investigational Site 183
Kobe, Japan
Boehringer Ingelheim Investigational Site 187
Kobe, Japan
Boehringer Ingelheim Investigational Site 185
Kobe, Japan
Boehringer Ingelheim Investigational Site 184
Kobe, Japan
Boehringer Ingelheim Investigational Site 220
Kochi, Japan
Boehringer Ingelheim Investigational Site 30
Koriyama, Japan
Boehringer Ingelheim Investigational Site 56
Koshigaya, Japan
Boehringer Ingelheim Investigational Site 193
Kotoura-cho, Japan
Boehringer Ingelheim Investigational Site 240
Kotouracho, Japan
Boehringer Ingelheim Investigational Site 53
Kumagaya, Japan
Boehringer Ingelheim Investigational Site 243
Kumamoto, Japan
Boehringer Ingelheim Investigational Site 196
Kurashiki, Japan
Boehringer Ingelheim Investigational Site 206
Kure, Japan
Boehringer Ingelheim Investigational Site 205
Kure, Japan
Boehringer Ingelheim Investigational Site 231
Kurume, Japan
Boehringer Ingelheim Investigational Site 230
Kurume, Japan
Boehringer Ingelheim Investigational Site 149
Kusatsu, Japan
Boehringer Ingelheim Investigational Site 9
Kushiro, Japan
Boehringer Ingelheim Investigational Site 153
Kyoto, Japan
Boehringer Ingelheim Investigational Site 157
Kyoto, Japan
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Kyoto, Japan
Boehringer Ingelheim Investigational Site 154
Kyoto, Japan
Boehringer Ingelheim Investigational Site 155
Kyoto, Japan
Boehringer Ingelheim Investigational Site 99
Matsuda-machi, Japan
Boehringer Ingelheim Investigational Site 65
Matsudo, Japan
Boehringer Ingelheim Investigational Site 64
Matsudo, Japan
Boehringer Ingelheim Investigational Site 195
Matsue, Japan
Boehringer Ingelheim Investigational Site 119
Matsumoto, Japan
Boehringer Ingelheim Investigational Site 120
Matsumoto, Japan
Boehringer Ingelheim Investigational Site 234
Matsuura, Japan
Boehringer Ingelheim Investigational Site 216
Matsuyama, Japan
Boehringer Ingelheim Investigational Site 217
Matsuyama, Japan
Boehringer Ingelheim Investigational Site 148
Matsuzaka, Japan
Boehringer Ingelheim Investigational Site 207
Mihara, Japan
Boehringer Ingelheim Investigational Site 122
Minamiminowa-mura, Japan
Boehringer Ingelheim Investigational Site 248
Miyazaki, Japan
Boehringer Ingelheim Investigational Site 126
Mizunami, Japan
Boehringer Ingelheim Investigational Site 60
Mobara, Japan
Boehringer Ingelheim Investigational Site 61
Mobara, Japan
Boehringer Ingelheim Investigational Site 16
Morioka, Japan
Boehringer Ingelheim Investigational Site 27
Murayama, Japan
Boehringer Ingelheim Investigational Site 106
Nagaoka, Japan
Boehringer Ingelheim Investigational Site 105
Nagaoka, Japan
Boehringer Ingelheim Investigational Site 235
Nagasaki, Japan
Boehringer Ingelheim Investigational Site 254
Nago, Japan
Boehringer Ingelheim Investigational Site 139
Nagoya, Japan
Boehringer Ingelheim Investigational Site 140
Nagoya, Japan
Boehringer Ingelheim Investigational Site 141
Nagoya, Japan
Boehringer Ingelheim Investigational Site 142
Nagoya, Japan
Boehringer Ingelheim Investigational Site 39
Nakagawa-machi, Japan
Boehringer Ingelheim Investigational Site 228
Nakagawa-machi, Japan
Boehringer Ingelheim Investigational Site 245
Nakatsu, Japan
Boehringer Ingelheim Investigational Site 127
Nakatsugawa, Japan
Boehringer Ingelheim Investigational Site 59
Narita, Japan
Boehringer Ingelheim Investigational Site 18
Natori, Japan
Boehringer Ingelheim Investigational Site 8
Nayoro, Japan
Boehringer Ingelheim Investigational Site 246
Nichinan, Japan
Boehringer Ingelheim Investigational Site 31
Nihonmatsu, Japan
Boehringer Ingelheim Investigational Site 107
Niigata, Japan
Boehringer Ingelheim Investigational Site 200
Niimi, Japan
Boehringer Ingelheim Investigational Site 6
Nikki-cho, Japan
Boehringer Ingelheim Investigational Site 128
Nishiizu-cho, Japan
Boehringer Ingelheim Investigational Site 182
Nishinomiya, Japan
Boehringer Ingelheim Investigational Site 112
Nomi, Japan
Boehringer Ingelheim Investigational Site 134
Numazu, Japan
Boehringer Ingelheim Investigational Site 26
Odate, Japan
Boehringer Ingelheim Investigational Site 124
Ogaki, Japan
Boehringer Ingelheim Investigational Site 244
Oita, Japan
Boehringer Ingelheim Investigational Site 197
Okayama, Japan
Boehringer Ingelheim Investigational Site 198
Okayama, Japan
Boehringer Ingelheim Investigational Site 14
Omamachi, Japan
Boehringer Ingelheim Investigational Site 239
Omura, Japan
Boehringer Ingelheim Investigational Site 163
Osaka, Japan
Boehringer Ingelheim Investigational Site 165
Osaka, Japan
Boehringer Ingelheim Investigational Site 166
Osaka, Japan
Boehringer Ingelheim Investigational Site 167
Osaka, Japan
Boehringer Ingelheim Investigational Site 168
Osaka, Japan
Boehringer Ingelheim Investigational Site 164
Osaka, Japan
Boehringer Ingelheim Investigational Site 162
Osaka, Japan
Boehringer Ingelheim Investigational Site 159
Osaka, Japan
Boehringer Ingelheim Investigational Site 160
Osaka, Japan
Boehringer Ingelheim Investigational Site 161
Osaka, Japan
Boehringer Ingelheim Investigational Site 40
Oyama, Japan
Boehringer Ingelheim Investigational Site 35
Ryugasaki, Japan
Boehringer Ingelheim Investigational Site 236
Saga, Japan
Boehringer Ingelheim Investigational Site 102
Sagamihara, Japan
Boehringer Ingelheim Investigational Site 47
Saitama, Japan
Boehringer Ingelheim Investigational Site 46
Saitama, Japan
Boehringer Ingelheim Investigational Site 172
Sakai, Japan
Boehringer Ingelheim Investigational Site 173
Sakai, Japan
Boehringer Ingelheim Investigational Site 215
Sakaide, Japan
Boehringer Ingelheim Investigational Site 118
Sakaki-machi, Japan
Boehringer Ingelheim Investigational Site 108
Sanjyo, Japan
Boehringer Ingelheim Investigational Site 41
Sano, Japan
Boehringer Ingelheim Investigational Site 1
Sapporo, Japan
Boehringer Ingelheim Investigational Site 3
Sapporo, Japan
Boehringer Ingelheim Investigational Site 2
Sapporo, Japan
Boehringer Ingelheim Investigational Site 55
Sayama, Japan
Boehringer Ingelheim Investigational Site 21
Sendai, Japan
Boehringer Ingelheim Investigational Site 115
Shika-machi, Japan
Boehringer Ingelheim Investigational Site 210
Shimonoseki, Japan
Boehringer Ingelheim Investigational Site 19
Shiogama, Japan
Boehringer Ingelheim Investigational Site 32
Shirakawa, Japan
Boehringer Ingelheim Investigational Site 133
Shizuoka, Japan
Boehringer Ingelheim Investigational Site 132
Shizuoka, Japan
Boehringer Ingelheim Investigational Site 50
Soka, Japan
Boehringer Ingelheim Investigational Site 174
Suita, Japan
Boehringer Ingelheim Investigational Site 147
Suzuka, Japan
Boehringer Ingelheim Investigational Site 71
Tachikawa, Japan
Boehringer Ingelheim Investigational Site 70
Tachikawa, Japan
Boehringer Ingelheim Investigational Site 69
Tachikawa, Japan
Boehringer Ingelheim Investigational Site 20
Tagajyo, Japan
Boehringer Ingelheim Investigational Site 45
Takasaki, Japan
Boehringer Ingelheim Investigational Site 44
Takasaki, Japan
Boehringer Ingelheim Investigational Site 150
Takashima, Japan
Boehringer Ingelheim Investigational Site 84
Tama, Japan
Boehringer Ingelheim Investigational Site 28
Tendo, Japan
Boehringer Ingelheim Investigational Site 109
Tokamachi, Japan
Boehringer Ingelheim Investigational Site 213
Tokushima, Japan
Boehringer Ingelheim Investigational Site 73
Tokyo Adachi-ku, Japan
Boehringer Ingelheim Investigational Site 72
Tokyo Adachi-ku, Japan
Boehringer Ingelheim Investigational Site 75
Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site 74
Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site 79
Tokyo Chuo-ku, Japan
Boehringer Ingelheim Investigational Site 77
Tokyo Edofawa-ku, Japan
Boehringer Ingelheim Investigational Site 76
Tokyo Itabashi-ku, Japan
Boehringer Ingelheim Investigational Site 89
Tokyo Katsushika-ku, Japan
Boehringer Ingelheim Investigational Site 85
Tokyo Meguro-ku, Japan
Boehringer Ingelheim Investigational Site 86
Tokyo Meguro-ku, Japan
Boehringer Ingelheim Investigational Site 82
Tokyo Nerima-ku, Japan
Boehringer Ingelheim Investigational Site 81
Tokyo Nerima-ku, Japan
Boehringer Ingelheim Investigational Site 87
Tokyo Ota-ku, Japan
Boehringer Ingelheim Investigational Site 68
Tokyo Shinjyuku-ku, Japan
Boehringer Ingelheim Investigational Site 67
Tokyo Shinjyuku-ku, Japan
Boehringer Ingelheim Investigational Site 88
Tokyo Sumida-ku, Japan
Boehringer Ingelheim Investigational Site 78
Tokyo Sumida-ku, Japan
Boehringer Ingelheim Investigational Site 80
Tokyo Toshima-ku, Japan
Boehringer Ingelheim Investigational Site 214
Tonosho-cho, Japan
Boehringer Ingelheim Investigational Site 221
Tosashimizu, Japan
Boehringer Ingelheim Investigational Site 110
Toyama, Japan
Boehringer Ingelheim Investigational Site 135
Toyohashi, Japan
Boehringer Ingelheim Investigational Site 136
Toyohashi, Japan
Boehringer Ingelheim Investigational Site 146
Tsu, Japan
Boehringer Ingelheim Investigational Site 36
Tsuchiura, Japan
Boehringer Ingelheim Investigational Site 247
Tsunocho, Japan
Boehringer Ingelheim Investigational Site 209
Ube, Japan
Boehringer Ingelheim Investigational Site 123
Ueda, Japan
Boehringer Ingelheim Investigational Site 42
Utsunomiya, Japan
Boehringer Ingelheim Investigational Site 218
Uwajima, Japan
Boehringer Ingelheim Investigational Site 251
Wadomari-cho, Japan
Boehringer Ingelheim Investigational Site 211
Yamaguchi, Japan
Boehringer Ingelheim Investigational Site 190
Yamatokooriyama, Japan
Boehringer Ingelheim Investigational Site 222
Yame, Japan
Boehringer Ingelheim Investigational Site 93
Yokohama, Japan
Boehringer Ingelheim Investigational Site 95
Yokohama, Japan
Boehringer Ingelheim Investigational Site 96
Yokohama, Japan
Boehringer Ingelheim Investigational Site 97
Yokohama, Japan
Boehringer Ingelheim Investigational Site 94
Yokohama, Japan
Boehringer Ingelheim Investigational Site 92
Yokosuka, Japan
Boehringer Ingelheim Investigational Site 91
Yokosuka, Japan
Boehringer Ingelheim Investigational Site 54
Yokoze-machi, Japan
Boehringer Ingelheim Investigational Site 194
Yonago, Japan
Boehringer Ingelheim Investigational Site 98
Zama, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01353274     History of Changes
Other Study ID Numbers: 1235.38
Study First Received: May 9, 2011
Results First Received: July 30, 2014
Last Updated: July 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014