Hypertension Clinical Trial
Official title:
Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension
| Verified date | July 2014 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension
| Status | Completed |
| Enrollment | 1157 |
| Est. completion date | August 2013 |
| Est. primary completion date | August 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| 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 57 | Chiba | |
| Japan | Boehringer Ingelheim Investigational Site 58 | Chiba | |
| Japan | Boehringer Ingelheim Investigational Site 232 | Chikuzen-machi | |
| Japan | Boehringer Ingelheim Investigational Site 143 | Chita | |
| Japan | Boehringer Ingelheim Investigational Site 23 | Daisen | |
| Japan | Boehringer Ingelheim Investigational Site 24 | 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 224 | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site 225 | 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 180 | Himeji | |
| Japan | Boehringer Ingelheim Investigational Site 181 | Himeji | |
| Japan | Boehringer Ingelheim Investigational Site 169 | Hirakata | |
| Japan | Boehringer Ingelheim Investigational Site 170 | Hirakata | |
| Japan | Boehringer Ingelheim Investigational Site 201 | Hiroshima | |
| Japan | Boehringer Ingelheim Investigational Site 202 | Hiroshima | |
| Japan | Boehringer Ingelheim Investigational Site 203 | 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 249 | Kagoshima | |
| Japan | Boehringer Ingelheim Investigational Site 250 | 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 33 | Kasama | |
| Japan | Boehringer Ingelheim Investigational Site 34 | Kasama | |
| Japan | Boehringer Ingelheim Investigational Site 137 | Kasugai | |
| Japan | Boehringer Ingelheim Investigational Site 138 | Kasugai | |
| Japan | Boehringer Ingelheim Investigational Site 48 | Kasukabe | |
| Japan | Boehringer Ingelheim Investigational Site 49 | Kasukabe | |
| Japan | Boehringer Ingelheim Investigational Site 177 | Kato | |
| Japan | Boehringer Ingelheim Investigational Site 178 | 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 183 | Kobe | |
| Japan | Boehringer Ingelheim Investigational Site 184 | Kobe | |
| Japan | Boehringer Ingelheim Investigational Site 185 | Kobe | |
| Japan | Boehringer Ingelheim Investigational Site 186 | Kobe | |
| Japan | Boehringer Ingelheim Investigational Site 187 | 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 205 | Kure | |
| Japan | Boehringer Ingelheim Investigational Site 206 | Kure | |
| Japan | Boehringer Ingelheim Investigational Site 230 | Kurume | |
| Japan | Boehringer Ingelheim Investigational Site 231 | 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 154 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 155 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 156 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 157 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 99 | Matsuda-machi | |
| Japan | Boehringer Ingelheim Investigational Site 64 | Matsudo | |
| Japan | Boehringer Ingelheim Investigational Site 65 | 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 105 | Nagaoka | |
| Japan | Boehringer Ingelheim Investigational Site 106 | 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 228 | Nakagawa-machi | |
| Japan | Boehringer Ingelheim Investigational Site 39 | 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 159 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 160 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 161 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 162 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 163 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 164 | 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 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 46 | Saitama | |
| Japan | Boehringer Ingelheim Investigational Site 47 | 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 2 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 3 | 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 132 | Shizuoka | |
| Japan | Boehringer Ingelheim Investigational Site 133 | 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 69 | Tachikawa | |
| Japan | Boehringer Ingelheim Investigational Site 70 | Tachikawa | |
| Japan | Boehringer Ingelheim Investigational Site 71 | Tachikawa | |
| Japan | Boehringer Ingelheim Investigational Site 20 | Tagajyo | |
| Japan | Boehringer Ingelheim Investigational Site 44 | Takasaki | |
| Japan | Boehringer Ingelheim Investigational Site 45 | 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 72 | Tokyo Adachi-ku | |
| Japan | Boehringer Ingelheim Investigational Site 73 | Tokyo Adachi-ku | |
| Japan | Boehringer Ingelheim Investigational Site 74 | Tokyo Bunkyo-ku | |
| Japan | Boehringer Ingelheim Investigational Site 75 | 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 81 | Tokyo Nerima-ku | |
| Japan | Boehringer Ingelheim Investigational Site 82 | Tokyo Nerima-ku | |
| Japan | Boehringer Ingelheim Investigational Site 87 | Tokyo Ota-ku | |
| Japan | Boehringer Ingelheim Investigational Site 67 | Tokyo Shinjyuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site 68 | Tokyo Shinjyuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site 78 | Tokyo Sumida-ku | |
| Japan | Boehringer Ingelheim Investigational Site 88 | 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 94 | 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 91 | Yokosuka | |
| Japan | Boehringer Ingelheim Investigational Site 92 | Yokosuka | |
| Japan | Boehringer Ingelheim Investigational Site 54 | Yokoze-machi | |
| Japan | Boehringer Ingelheim Investigational Site 194 | Yonago | |
| Japan | Boehringer Ingelheim Investigational Site 98 | Zama |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of Drug-related Adverse Events | Number of patients with drug-related adverse events | 12 months | No |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) | Change from baseline in SBP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | No |
| Secondary | Change From Baseline in Diastolic Blood Pressure (DBP) | Change from baseline in DBP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | No |
| Secondary | Proportion of Patients Who Achieved the Target BP | Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | No |
| Secondary | Proportion of Patients Who Normalised Their BP | Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | No |
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