Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

An observational study of Hypertension, run by Boehringer Ingelheim at 314 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Telmisartan 80mg, Telmisartan 40mg and Hydrochlorothiazide 12.5mg
Type of treatment: Pill or oral medicine
How many people: 1,452 participants
Where: 314 sitesJapan
Study dates: Jan 2010to Dec 2011
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 1000

Who may be able to join

Hypertensive patients who have never taken Micombi Tablets.

Who cannot join

None

Trial locations and contacts

314 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

Japan300 sites

Boehringer Ingelheim Investigational Site 111
Ageo
Boehringer Ingelheim Investigational Site 209
Aisho-cho
Boehringer Ingelheim Investigational Site 22
Aizubange-machi
Boehringer Ingelheim Investigational Site 234
Akashi
Boehringer Ingelheim Investigational Site 78
Akiruno
Boehringer Ingelheim Investigational Site 79
Akishima
Boehringer Ingelheim Investigational Site 235
Akō
Boehringer Ingelheim Investigational Site 288
Akune
Boehringer Ingelheim Investigational Site 236
Amagasaki
Boehringer Ingelheim Investigational Site 237
Amagasaki
Boehringer Ingelheim Investigational Site 280
Anan
Boehringer Ingelheim Investigational Site 160
Anjo
Boehringer Ingelheim Investigational Site 1
Asahikawa
Boehringer Ingelheim Investigational Site 51
Ashikaga
Boehringer Ingelheim Investigational Site 140
Atsugi
Boehringer Ingelheim Investigational Site 58
Azumino
Boehringer Ingelheim Investigational Site 128
Chiba
Boehringer Ingelheim Investigational Site 138
Chiba
Boehringer Ingelheim Investigational Site 141
Chigasaki
Boehringer Ingelheim Investigational Site 299
Chikujo-machi
Boehringer Ingelheim Investigational Site 44
Chikusei
Boehringer Ingelheim Investigational Site 80
Chōfu
Boehringer Ingelheim Investigational Site 311
Ebino
Boehringer Ingelheim Investigational Site 257
Fuchū
Boehringer Ingelheim Investigational Site 71
Fuefuki
Boehringer Ingelheim Investigational Site 179
Fujieda
Boehringer Ingelheim Investigational Site 211
Fujiidera
Boehringer Ingelheim Investigational Site 112
Fukaya
Boehringer Ingelheim Investigational Site 206
Fukui
Boehringer Ingelheim Investigational Site 300
Fukuoka
Boehringer Ingelheim Investigational Site 301
Fukuoka
Boehringer Ingelheim Investigational Site 302
Fukuoka
Boehringer Ingelheim Investigational Site 303
Fukuoka
Boehringer Ingelheim Investigational Site 180
Fukuroi
Boehringer Ingelheim Investigational Site 23
Fukushima
Boehringer Ingelheim Investigational Site 258
Fukuyama
Boehringer Ingelheim Investigational Site 129
Funabashi
Boehringer Ingelheim Investigational Site 47
Funaishikawa
Boehringer Ingelheim Investigational Site 174
Gifu
Boehringer Ingelheim Investigational Site 175
Gifu
Boehringer Ingelheim Investigational Site 42
Gonohe-machi
Boehringer Ingelheim Investigational Site 113
Gyōda
Boehringer Ingelheim Investigational Site 212
Habikino
Boehringer Ingelheim Investigational Site 81
Hachiōji
Boehringer Ingelheim Investigational Site 82
Hachiōji
Boehringer Ingelheim Investigational Site 193
Hakusan
Boehringer Ingelheim Investigational Site 181
Hamamatsu
Boehringer Ingelheim Investigational Site 247
Hashimoto
Boehringer Ingelheim Investigational Site 142
Hatano
Boehringer Ingelheim Investigational Site 259
Hatsukaichi
Boehringer Ingelheim Investigational Site 114
Higashi-Matsuyama
Boehringer Ingelheim Investigational Site 276
Higashikagawa
Boehringer Ingelheim Investigational Site 83
Higashikurume
Boehringer Ingelheim Investigational Site 213
Higashiosaka
Boehringer Ingelheim Investigational Site 84
Hino
Boehringer Ingelheim Investigational Site 43
Hirosaki
Boehringer Ingelheim Investigational Site 260
Hiroshima
Boehringer Ingelheim Investigational Site 261
Hiroshima
Boehringer Ingelheim Investigational Site 262
Hiroshima
Boehringer Ingelheim Investigational Site 263
Hiroshima
Boehringer Ingelheim Investigational Site 45
Hitachi-Naka
Boehringer Ingelheim Investigational Site 266
Hōfu
Boehringer Ingelheim Investigational Site 72
Hokuto
Boehringer Ingelheim Investigational Site 249
Ibara
Boehringer Ingelheim Investigational Site 214
Ibaraki
Boehringer Ingelheim Investigational Site 215
Ibaraki
Boehringer Ingelheim Investigational Site 130
Ichikawa
Boehringer Ingelheim Investigational Site 161
Ichinomiya
Boehringer Ingelheim Investigational Site 18
Ichinoseki
Boehringer Ingelheim Investigational Site 19
Ichinoseki
Boehringer Ingelheim Investigational Site 59
Ina
Boehringer Ingelheim Investigational Site 289
Isa
Boehringer Ingelheim Investigational Site 187
Ise
Boehringer Ingelheim Investigational Site 74
Isesaki
Boehringer Ingelheim Investigational Site 182
Itō
Boehringer Ingelheim Investigational Site 52
Iwafune-machi
Boehringer Ingelheim Investigational Site 24
Iwaki
Boehringer Ingelheim Investigational Site 162
Iwakura
Boehringer Ingelheim Investigational Site 216
Izumisano
Boehringer Ingelheim Investigational Site 194
Kaga
Boehringer Ingelheim Investigational Site 290
Kagoshima
Boehringer Ingelheim Investigational Site 73
Kai
Boehringer Ingelheim Investigational Site 195
Kanazawa
Boehringer Ingelheim Investigational Site 53
Kanuma
Boehringer Ingelheim Investigational Site 163
Kariya
Boehringer Ingelheim Investigational Site 238
Kasai
Boehringer Ingelheim Investigational Site 164
Kasugai
Boehringer Ingelheim Investigational Site 115
Kasukabe
Boehringer Ingelheim Investigational Site 217
Kawachi-Nagano
Boehringer Ingelheim Investigational Site 116
Kawaguchi
Boehringer Ingelheim Investigational Site 117
Kawaguchi
Boehringer Ingelheim Investigational Site 231
Kawaichō
Boehringer Ingelheim Investigational Site 143
Kawasaki
Boehringer Ingelheim Investigational Site 144
Kawasaki
Boehringer Ingelheim Investigational Site 145
Kawasaki
Boehringer Ingelheim Investigational Site 296
Kawatana-cho
Boehringer Ingelheim Investigational Site 40
Kazuno
Boehringer Ingelheim Investigational Site 29
Kesennuma
Boehringer Ingelheim Investigational Site 131
Kisarazu
Boehringer Ingelheim Investigational Site 2
Kitahiroshima
Boehringer Ingelheim Investigational Site 304
Kitakyushu
Boehringer Ingelheim Investigational Site 305
Kitakyushu
Boehringer Ingelheim Investigational Site 306
Kitakyushu
Boehringer Ingelheim Investigational Site 239
Kobe
Boehringer Ingelheim Investigational Site 240
Kobe
Boehringer Ingelheim Investigational Site 241
Kobe
Boehringer Ingelheim Investigational Site 242
Kobe
Boehringer Ingelheim Investigational Site 25
Kōriyama
Boehringer Ingelheim Investigational Site 118
Koshigaya
Boehringer Ingelheim Investigational Site 277
Kotohira
Boehringer Ingelheim Investigational Site 119
Kumagaya
Boehringer Ingelheim Investigational Site 291
Kumamoto
Boehringer Ingelheim Investigational Site 292
Kumamoto
Boehringer Ingelheim Investigational Site 284
Kunisaki
Boehringer Ingelheim Investigational Site 250
Kurashiki
Boehringer Ingelheim Investigational Site 264
Kure
Boehringer Ingelheim Investigational Site 265
Kure
Boehringer Ingelheim Investigational Site 285
Kusu-machi
Boehringer Ingelheim Investigational Site 197
Kyoto
Boehringer Ingelheim Investigational Site 198
Kyoto
Boehringer Ingelheim Investigational Site 199
Kyoto
Boehringer Ingelheim Investigational Site 200
Kyoto
Boehringer Ingelheim Investigational Site 85
Machida
Boehringer Ingelheim Investigational Site 307
Maebaru
Boehringer Ingelheim Investigational Site 146
Matsuda-machi
Boehringer Ingelheim Investigational Site 132
Matsudo
Boehringer Ingelheim Investigational Site 60
Matsumoto
Boehringer Ingelheim Investigational Site 61
Matsumoto
Boehringer Ingelheim Investigational Site 272
Matsuyama
Boehringer Ingelheim Investigational Site 273
Matsuyama
Boehringer Ingelheim Investigational Site 188
Matsuzaka
Boehringer Ingelheim Investigational Site 293
Minamata
Boehringer Ingelheim Investigational Site 30
Minamisanriku
Boehringer Ingelheim Investigational Site 218
Minoo
Boehringer Ingelheim Investigational Site 46
Mito
Boehringer Ingelheim Investigational Site 312
Miyazaki
Boehringer Ingelheim Investigational Site 133
Mobara
Boehringer Ingelheim Investigational Site 20
Morioka
Boehringer Ingelheim Investigational Site 26
Motomiya
Boehringer Ingelheim Investigational Site 3
Mukawa-cho
Boehringer Ingelheim Investigational Site 86
Musashino
Boehringer Ingelheim Investigational Site 62
Nagano
Boehringer Ingelheim Investigational Site 63
Nagano
Boehringer Ingelheim Investigational Site 297
Nagasaki
Boehringer Ingelheim Investigational Site 165
Nagoya
Boehringer Ingelheim Investigational Site 166
Nagoya
Boehringer Ingelheim Investigational Site 167
Nagoya
Boehringer Ingelheim Investigational Site 168
Nagoya
Boehringer Ingelheim Investigational Site 192
Nagoya
Boehringer Ingelheim Investigational Site 314
Naha
Boehringer Ingelheim Investigational Site 41
Nakadōri
Boehringer Ingelheim Investigational Site 54
Nakagawamachi
Boehringer Ingelheim Investigational Site 176
Nakatsugawa
Boehringer Ingelheim Investigational Site 196
Nanao
Boehringer Ingelheim Investigational Site 278
Nankoku
Boehringer Ingelheim Investigational Site 232
Nara
Boehringer Ingelheim Investigational Site 31
Natori
Boehringer Ingelheim Investigational Site 4
Nayoro
Boehringer Ingelheim Investigational Site 313
Nichinan
Boehringer Ingelheim Investigational Site 65
Niigata
Boehringer Ingelheim Investigational Site 66
Niigata
Boehringer Ingelheim Investigational Site 147
Ninomiya-machi
Boehringer Ingelheim Investigational Site 243
Nishinomiya
Boehringer Ingelheim Investigational Site 244
Nishinomiya
Boehringer Ingelheim Investigational Site 169
Nishio
Boehringer Ingelheim Investigational Site 87
Nishitōkyō
Boehringer Ingelheim Investigational Site 5
Obihiro
Boehringer Ingelheim Investigational Site 255
Oda
Boehringer Ingelheim Investigational Site 189
Odai-cho
Boehringer Ingelheim Investigational Site 16
Ōdate
Boehringer Ingelheim Investigational Site 148
Odawara
Boehringer Ingelheim Investigational Site 294
Ogi
Boehringer Ingelheim Investigational Site 286
Ōita
Boehringer Ingelheim Investigational Site 287
Ōita
Boehringer Ingelheim Investigational Site 251
Okayama
Boehringer Ingelheim Investigational Site 252
Okayama
Boehringer Ingelheim Investigational Site 253
Okayama
Boehringer Ingelheim Investigational Site 308
Omuta
Boehringer Ingelheim Investigational Site 309
Omuta
Boehringer Ingelheim Investigational Site 219
Osaka
Boehringer Ingelheim Investigational Site 220
Osaka
Boehringer Ingelheim Investigational Site 221
Osaka
Boehringer Ingelheim Investigational Site 222
Osaka
Boehringer Ingelheim Investigational Site 223
Osaka
Boehringer Ingelheim Investigational Site 224
Osaka
Boehringer Ingelheim Investigational Site 225
Osaka
Boehringer Ingelheim Investigational Site 226
Osaka
Boehringer Ingelheim Investigational Site 21
Ōshū
Boehringer Ingelheim Investigational Site 6
Otaru
Boehringer Ingelheim Investigational Site 210
Ōtsu
Boehringer Ingelheim Investigational Site 75
Ōuramachi
Boehringer Ingelheim Investigational Site 55
Oyama
Boehringer Ingelheim Investigational Site 67
Sado
Boehringer Ingelheim Investigational Site 149
Sagamihara
Boehringer Ingelheim Investigational Site 150
Sagamihara
Boehringer Ingelheim Investigational Site 274
Saijō
Boehringer Ingelheim Investigational Site 120
Saitama
Boehringer Ingelheim Investigational Site 121
Saitama
Boehringer Ingelheim Investigational Site 122
Saitama
Boehringer Ingelheim Investigational Site 227
Sakai
Boehringer Ingelheim Investigational Site 228
Sakai
Boehringer Ingelheim Investigational Site 229
Sakai
Boehringer Ingelheim Investigational Site 39
Sakata
Boehringer Ingelheim Investigational Site 134
Sakura
Boehringer Ingelheim Investigational Site 68
Sanjō
Boehringer Ingelheim Investigational Site 135
Sanmu
Boehringer Ingelheim Investigational Site 267
Sanyōonoda
Boehringer Ingelheim Investigational Site 268
Sanyōonoda
Boehringer Ingelheim Investigational Site 10
Sapporo
Boehringer Ingelheim Investigational Site 11
Sapporo
Boehringer Ingelheim Investigational Site 12
Sapporo
Boehringer Ingelheim Investigational Site 7
Sapporo
Boehringer Ingelheim Investigational Site 8
Sapporo
Boehringer Ingelheim Investigational Site 9
Sapporo
Boehringer Ingelheim Investigational Site 298
Sasebo
Boehringer Ingelheim Investigational Site 123
Satte
Boehringer Ingelheim Investigational Site 124
Sayama
Boehringer Ingelheim Investigational Site 32
Sendai
Boehringer Ingelheim Investigational Site 33
Sendai
Boehringer Ingelheim Investigational Site 34
Sendai
Boehringer Ingelheim Investigational Site 35
Sendai
Boehringer Ingelheim Investigational Site 36
Sendai
Boehringer Ingelheim Investigational Site 37
Sendai
Boehringer Ingelheim Investigational Site 69
Shibata
Boehringer Ingelheim Investigational Site 13
Shibetsu
Boehringer Ingelheim Investigational Site 125
Shiki
Boehringer Ingelheim Investigational Site 279
Shimanto
Boehringer Ingelheim Investigational Site 310
Shime-machi
Boehringer Ingelheim Investigational Site 183
Shimoda
Boehringer Ingelheim Investigational Site 248
Shingū
Boehringer Ingelheim Investigational Site 38
Shiraishi
Boehringer Ingelheim Investigational Site 136
Shiroi
Boehringer Ingelheim Investigational Site 184
Shizuoka
Boehringer Ingelheim Investigational Site 185
Shizuoka
Boehringer Ingelheim Investigational Site 269
Shūnan
Boehringer Ingelheim Investigational Site 126
Sōka
Boehringer Ingelheim Investigational Site 27
Sukagawa
Boehringer Ingelheim Investigational Site 190
Suzuka
Boehringer Ingelheim Investigational Site 88
Tachikawa
Boehringer Ingelheim Investigational Site 203
Takaoka
Boehringer Ingelheim Investigational Site 204
Takaoka
Boehringer Ingelheim Investigational Site 245
Takarazuka
Boehringer Ingelheim Investigational Site 76
Takasaki
Boehringer Ingelheim Investigational Site 77
Takasaki
Boehringer Ingelheim Investigational Site 177
Takayama
Boehringer Ingelheim Investigational Site 246
Tatsuno
Boehringer Ingelheim Investigational Site 70
Tōkamachi
Boehringer Ingelheim Investigational Site 170
Tokoname
Boehringer Ingelheim Investigational Site 127
Tokorozawa
Boehringer Ingelheim Investigational Site 281
Tokushima
Boehringer Ingelheim Investigational Site 282
Tokushima
Boehringer Ingelheim Investigational Site 89
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site 90
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site 102
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 91
Tokyo Chiyoda-ku
Boehringer Ingelheim Investigational Site 92
Tokyo Chiyoda-ku
Boehringer Ingelheim Investigational Site 93
Tokyo Kita-ku
Boehringer Ingelheim Investigational Site 94
Tokyo Koto-ku
Boehringer Ingelheim Investigational Site 95
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 96
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 97
Tokyo Nerima-ku
Boehringer Ingelheim Investigational Site 98
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site 99
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site 100
Tokyo Setagaya-ku
Boehringer Ingelheim Investigational Site 101
Tokyo Setagaya-ku
Boehringer Ingelheim Investigational Site 103
Tokyo Shibuya-ku
Boehringer Ingelheim Investigational Site 104
Tokyo Shinagawa-ku
Boehringer Ingelheim Investigational Site 105
Tokyo Shinagawa-ku
Boehringer Ingelheim Investigational Site 106
Tokyo Shinagawa-ku
Boehringer Ingelheim Investigational Site 107
Tokyo Shinjuku-ku
Boehringer Ingelheim Investigational Site 108
Tokyo Suginami-ku
Boehringer Ingelheim Investigational Site 109
Tokyo Sumida-ku
Boehringer Ingelheim Investigational Site 110
Tokyo Toshima-ku
Boehringer Ingelheim Investigational Site 14
Tomakomai
Boehringer Ingelheim Investigational Site 28
Tomioka
Boehringer Ingelheim Investigational Site 295
Tosu
Boehringer Ingelheim Investigational Site 270
Tottori
Boehringer Ingelheim Investigational Site 15
Toyako-machi
Boehringer Ingelheim Investigational Site 205
Toyama
Boehringer Ingelheim Investigational Site 171
Toyohashi
Boehringer Ingelheim Investigational Site 172
Toyokawa
Boehringer Ingelheim Investigational Site 230
Toyonaka
Boehringer Ingelheim Investigational Site 173
Toyota
Boehringer Ingelheim Investigational Site 49
Tsuchiura
Boehringer Ingelheim Investigational Site 207
Tsuruga
Boehringer Ingelheim Investigational Site 208
Tsuruga
Boehringer Ingelheim Investigational Site 283
Tsurugi-cho
Boehringer Ingelheim Investigational Site 254
Tsuyama
Boehringer Ingelheim Investigational Site 64
Ueda
Boehringer Ingelheim Investigational Site 201
Uji
Boehringer Ingelheim Investigational Site 48
Ushiku
Boehringer Ingelheim Investigational Site 56
Utsunomiya
Boehringer Ingelheim Investigational Site 57
Utsunomiya
Boehringer Ingelheim Investigational Site 275
Uwajima
Boehringer Ingelheim Investigational Site 137
Yachimata
Boehringer Ingelheim Investigational Site 186
Yaizu
Boehringer Ingelheim Investigational Site 178
Yamagata
Boehringer Ingelheim Investigational Site 151
Yamato
Boehringer Ingelheim Investigational Site 233
Yamatokooriyama
Boehringer Ingelheim Investigational Site 191
Yokkaichi

Other trials in Japan

About this study

Official title: Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension

The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.

Conditions: Hypertension
Being tested: Telmisartan 80mg, Telmisartan 40mg, Hydrochlorothiazide 12.5mg
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telmisartan 80mgDrug
Combination tablet
Telmisartan 40mgDrug
Combination tablet
Hydrochlorothiazide 12.5mgDrug
Combination tablet

Study groups in NCT01050062
Study group	Role	What they receive
Micombi® Combination Tablet AP		Not described Receives: Drug: Telmisartan 40mg; Drug: Hydrochlorothiazide 12.5mg
Micombi® Combination Tablet BP		Not described Receives: Drug: Telmisartan 80mg; Drug: Hydrochlorothiazide 12.5mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Adverse Events (AEs)
The number of patient with any AEs, patients with drug-related AEs
Measured: Week 52

Secondary outcomes (4)

Systolic Blood Pressure (SBP)
SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
Measured: Week 0 and Week 52
Diastolic Blood Pressure (DBP)
DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
Measured: Week 0 and Week 52
Target Blood Pressure Achievement Rate
The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
Measured: Week 52
Blood Pressure Normalised Rate
The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009
Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2011

First posted15 Jan 2010 (estimated)
Study startJan 2010
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,452 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01050062
Sponsor's protocol ID: 502.542
Status last verified: Apr 2014
First submitted: 24 Dec 2009
Last updated: 1 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension
ClinicalTrials.gov ID: NCT01050062
Acronym / sponsor ID: 502.542
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 1,452 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Inc
Study start: Jan 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 15 Jan 2010 (estimated)
Results: Posted 30 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Micombi® Combination Tablet AP	–	Drug: Telmisartan 40mg, Drug: Hydrochlorothiazide 12.5mg
Micombi® Combination Tablet BP	–	Drug: Telmisartan 80mg, Drug: Hydrochlorothiazide 12.5mg

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 1000

Key inclusion criteria (1 listed)

Hypertensive patients who have never taken Micombi Tablets.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telmisartan 80mgCombination tablet	Drug	Micombi® Combination Tablet BP
Telmisartan 40mgCombination tablet	Drug	Micombi® Combination Tablet AP
Hydrochlorothiazide 12.5mgCombination tablet	Drug	Micombi® Combination Tablet AP, Micombi® Combination Tablet BP

Primary outcome

Incidence of Adverse Events (AEs)
Time frame: Week 52
The number of patient with any AEs, patients with drug-related AEs

4 secondary outcomes

Systolic Blood Pressure (SBP)
Time frame: Week 0 and Week 52
Diastolic Blood Pressure (DBP)
Time frame: Week 0 and Week 52
Target Blood Pressure Achievement Rate
Time frame: Week 52
Blood Pressure Normalised Rate
Time frame: Week 52

Results and safety

Results posted to the registry on 30 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Tablet AP	1,070	799
Combination Tablet BP	355	243

Primary outcome: Incidence of Adverse Events (AEs)

Time frame: Week 52. Number. Unit: Patients

Measure	Combination Tablet AP n = 1070	Combination Tablet BP n = 355	Total n = 1425
patient with any AEs	221	72	293
patients with drug-related AEs	154	46	200

Population analysed: The all treated patients, 18 patients which were no information including safety due to no visit after enrolled. Then, total 1425 patients were observed in the survey

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 52 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Tablet Ap	25 of 1,070 (2.3%)	0 of 1,070 (0%)	Not reported
Combination Tablet BP	12 of 355 (3.4%)	0 of 355 (0%)	Not reported
Total	37 of 1,425 (2.6%)	0 of 1,425 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

314 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 314 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 314 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01050062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.