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

An observational study of Hypertension, run by Boehringer Ingelheim at 254 sites in Japan.

Completed

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

Trial summary

Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension Read more about this study

Who is it for?: Any age
Conditions the study is for: Hypertension
What is being tested?: Micamlo
How many people: 1,157 participants
Where: 254 sitesJapan
Study dates: May 2011to Aug 2013
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: 1200

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

254 sites in 1 country.

City, postcode or hospital

254 sites in 1 country

Japan254 sites

Boehringer Ingelheim Investigational Site 199
Akaiwa
Boehringer Ingelheim Investigational Site 83
Akishima
Boehringer Ingelheim Investigational Site 25
Akita
Boehringer Ingelheim Investigational Site 188
Amagasaki
Boehringer Ingelheim Investigational Site 116
Anamizu-machi
Boehringer Ingelheim Investigational Site 212
Anan
Boehringer Ingelheim Investigational Site 145
Anjo
Boehringer Ingelheim Investigational Site 11
Aomori
Boehringer Ingelheim Investigational Site 12
Aomori
Boehringer Ingelheim Investigational Site 192
Arita
Boehringer Ingelheim Investigational Site 7
Asahikawa
Boehringer Ingelheim Investigational Site 104
Atsugi
Boehringer Ingelheim Investigational Site 57
Chiba
Boehringer Ingelheim Investigational Site 58
Chiba
Boehringer Ingelheim Investigational Site 232
Chikuzen-machi
Boehringer Ingelheim Investigational Site 143
Chita
Boehringer Ingelheim Investigational Site 23
Daisen
Boehringer Ingelheim Investigational Site 24
Daisen
Boehringer Ingelheim Investigational Site 10
Date
Boehringer Ingelheim Investigational Site 90
Fuchū
Boehringer Ingelheim Investigational Site 52
Fujimino
Boehringer Ingelheim Investigational Site 129
Fujinomiya
Boehringer Ingelheim Investigational Site 103
Fujisawa
Boehringer Ingelheim Investigational Site 158
Fukuchiyama
Boehringer Ingelheim Investigational Site 224
Fukuoka
Boehringer Ingelheim Investigational Site 225
Fukuoka
Boehringer Ingelheim Investigational Site 29
Fukushima
Boehringer Ingelheim Investigational Site 13
Hachinohe
Boehringer Ingelheim Investigational Site 130
Hamamatsu
Boehringer Ingelheim Investigational Site 131
Hamamatsu
Boehringer Ingelheim Investigational Site 219
Handa
Boehringer Ingelheim Investigational Site 171
Hannan
Boehringer Ingelheim Investigational Site 204
Hatsukaichi
Boehringer Ingelheim Investigational Site 208
Higashihiroshima
Boehringer Ingelheim Investigational Site 5
Higashikagura-cho
Boehringer Ingelheim Investigational Site 66
Higashimurayama
Boehringer Ingelheim Investigational Site 151
Hikone
Boehringer Ingelheim Investigational Site 179
Himeji
Boehringer Ingelheim Investigational Site 180
Himeji
Boehringer Ingelheim Investigational Site 181
Himeji
Boehringer Ingelheim Investigational Site 169
Hirakata
Boehringer Ingelheim Investigational Site 170
Hirakata
Boehringer Ingelheim Investigational Site 201
Hiroshima
Boehringer Ingelheim Investigational Site 202
Hiroshima
Boehringer Ingelheim Investigational Site 203
Hiroshima
Boehringer Ingelheim Investigational Site 38
Hitachi-Naka
Boehringer Ingelheim Investigational Site 37
Hitachiota
Boehringer Ingelheim Investigational Site 62
Ichikawa
Boehringer Ingelheim Investigational Site 17
Ichinoseki
Boehringer Ingelheim Investigational Site 223
Iizuka
Boehringer Ingelheim Investigational Site 175
Ikeda
Boehringer Ingelheim Investigational Site 238
Iki
Boehringer Ingelheim Investigational Site 63
IKisarazu
Boehringer Ingelheim Investigational Site 191
Ikoma
Boehringer Ingelheim Investigational Site 111
Imizu
Boehringer Ingelheim Investigational Site 189
Itami
Boehringer Ingelheim Investigational Site 253
Itoman
Boehringer Ingelheim Investigational Site 233
Itoshima
Boehringer Ingelheim Investigational Site 252
Izumi
Boehringer Ingelheim Investigational Site 249
Kagoshima
Boehringer Ingelheim Investigational Site 250
Kagoshima
Boehringer Ingelheim Investigational Site 125
Kakamigahara
Boehringer Ingelheim Investigational Site 229
Kama
Boehringer Ingelheim Investigational Site 152
Kameoka
Boehringer Ingelheim Investigational Site 241
Kamiamakusa
Boehringer Ingelheim Investigational Site 242
Kamiamakusa
Boehringer Ingelheim Investigational Site 22
Kamimachi
Boehringer Ingelheim Investigational Site 113
Kanazawa
Boehringer Ingelheim Investigational Site 114
Kanazawa
Boehringer Ingelheim Investigational Site 237
Kanzaki
Boehringer Ingelheim Investigational Site 144
Kariya
Boehringer Ingelheim Investigational Site 33
Kasama
Boehringer Ingelheim Investigational Site 34
Kasama
Boehringer Ingelheim Investigational Site 137
Kasugai
Boehringer Ingelheim Investigational Site 138
Kasugai
Boehringer Ingelheim Investigational Site 48
Kasukabe
Boehringer Ingelheim Investigational Site 49
Kasukabe
Boehringer Ingelheim Investigational Site 177
Katō
Boehringer Ingelheim Investigational Site 178
Katō
Boehringer Ingelheim Investigational Site 117
Katsuyama
Boehringer Ingelheim Investigational Site 121
Kawachi-Nagano
Boehringer Ingelheim Investigational Site 51
Kawaguchi
Boehringer Ingelheim Investigational Site 100
Kawasaki
Boehringer Ingelheim Investigational Site 101
Kawasaki
Boehringer Ingelheim Investigational Site 43
Kiryū
Boehringer Ingelheim Investigational Site 176
Kita-ku
Boehringer Ingelheim Investigational Site 15
Kitakami
Boehringer Ingelheim Investigational Site 226
Kitakyushu
Boehringer Ingelheim Investigational Site 227
Kitakyushu
Boehringer Ingelheim Investigational Site 4
Kitami
Boehringer Ingelheim Investigational Site 183
Kobe
Boehringer Ingelheim Investigational Site 184
Kobe
Boehringer Ingelheim Investigational Site 185
Kobe
Boehringer Ingelheim Investigational Site 186
Kobe
Boehringer Ingelheim Investigational Site 187
Kobe
Boehringer Ingelheim Investigational Site 220
Kochi
Boehringer Ingelheim Investigational Site 30
Kōriyama
Boehringer Ingelheim Investigational Site 56
Koshigaya
Boehringer Ingelheim Investigational Site 193
Kotoura-cho
Boehringer Ingelheim Investigational Site 240
Kotouracho
Boehringer Ingelheim Investigational Site 53
Kumagaya
Boehringer Ingelheim Investigational Site 243
Kumamoto
Boehringer Ingelheim Investigational Site 196
Kurashiki
Boehringer Ingelheim Investigational Site 205
Kure
Boehringer Ingelheim Investigational Site 206
Kure
Boehringer Ingelheim Investigational Site 230
Kurume
Boehringer Ingelheim Investigational Site 231
Kurume
Boehringer Ingelheim Investigational Site 149
Kusatsu
Boehringer Ingelheim Investigational Site 9
Kushiro
Boehringer Ingelheim Investigational Site 153
Kyoto
Boehringer Ingelheim Investigational Site 154
Kyoto
Boehringer Ingelheim Investigational Site 155
Kyoto
Boehringer Ingelheim Investigational Site 156
Kyoto
Boehringer Ingelheim Investigational Site 157
Kyoto
Boehringer Ingelheim Investigational Site 99
Matsuda-machi
Boehringer Ingelheim Investigational Site 64
Matsudo
Boehringer Ingelheim Investigational Site 65
Matsudo
Boehringer Ingelheim Investigational Site 195
Matsue
Boehringer Ingelheim Investigational Site 119
Matsumoto
Boehringer Ingelheim Investigational Site 120
Matsumoto
Boehringer Ingelheim Investigational Site 234
Matsuura
Boehringer Ingelheim Investigational Site 216
Matsuyama
Boehringer Ingelheim Investigational Site 217
Matsuyama
Boehringer Ingelheim Investigational Site 148
Matsuzaka
Boehringer Ingelheim Investigational Site 207
Mihara
Boehringer Ingelheim Investigational Site 122
Minamiminowa-mura
Boehringer Ingelheim Investigational Site 248
Miyazaki
Boehringer Ingelheim Investigational Site 126
Mizunami
Boehringer Ingelheim Investigational Site 60
Mobara
Boehringer Ingelheim Investigational Site 61
Mobara
Boehringer Ingelheim Investigational Site 16
Morioka
Boehringer Ingelheim Investigational Site 27
Murayama
Boehringer Ingelheim Investigational Site 105
Nagaoka
Boehringer Ingelheim Investigational Site 106
Nagaoka
Boehringer Ingelheim Investigational Site 235
Nagasaki
Boehringer Ingelheim Investigational Site 254
Nago
Boehringer Ingelheim Investigational Site 139
Nagoya
Boehringer Ingelheim Investigational Site 140
Nagoya
Boehringer Ingelheim Investigational Site 141
Nagoya
Boehringer Ingelheim Investigational Site 142
Nagoya
Boehringer Ingelheim Investigational Site 228
Nakagawamachi
Boehringer Ingelheim Investigational Site 39
Nakagawamachi
Boehringer Ingelheim Investigational Site 245
Nakatsu
Boehringer Ingelheim Investigational Site 127
Nakatsugawa
Boehringer Ingelheim Investigational Site 59
Narita
Boehringer Ingelheim Investigational Site 18
Natori
Boehringer Ingelheim Investigational Site 8
Nayoro
Boehringer Ingelheim Investigational Site 246
Nichinan
Boehringer Ingelheim Investigational Site 31
Nihonmatsu
Boehringer Ingelheim Investigational Site 107
Niigata
Boehringer Ingelheim Investigational Site 200
Niimi
Boehringer Ingelheim Investigational Site 6
Nikki-cho
Boehringer Ingelheim Investigational Site 128
Nishiizu-cho
Boehringer Ingelheim Investigational Site 182
Nishinomiya
Boehringer Ingelheim Investigational Site 112
Nomi
Boehringer Ingelheim Investigational Site 134
Numazu
Boehringer Ingelheim Investigational Site 26
Ōdate
Boehringer Ingelheim Investigational Site 124
Ōgaki
Boehringer Ingelheim Investigational Site 244
Ōita
Boehringer Ingelheim Investigational Site 197
Okayama
Boehringer Ingelheim Investigational Site 198
Okayama
Boehringer Ingelheim Investigational Site 14
Omamachi
Boehringer Ingelheim Investigational Site 239
Ōmura
Boehringer Ingelheim Investigational Site 159
Osaka
Boehringer Ingelheim Investigational Site 160
Osaka
Boehringer Ingelheim Investigational Site 161
Osaka
Boehringer Ingelheim Investigational Site 162
Osaka
Boehringer Ingelheim Investigational Site 163
Osaka
Boehringer Ingelheim Investigational Site 164
Osaka
Boehringer Ingelheim Investigational Site 165
Osaka
Boehringer Ingelheim Investigational Site 166
Osaka
Boehringer Ingelheim Investigational Site 167
Osaka
Boehringer Ingelheim Investigational Site 168
Osaka
Boehringer Ingelheim Investigational Site 40
Oyama
Boehringer Ingelheim Investigational Site 35
Ryūgasaki
Boehringer Ingelheim Investigational Site 236
Saga
Boehringer Ingelheim Investigational Site 102
Sagamihara
Boehringer Ingelheim Investigational Site 46
Saitama
Boehringer Ingelheim Investigational Site 47
Saitama
Boehringer Ingelheim Investigational Site 172
Sakai
Boehringer Ingelheim Investigational Site 173
Sakai
Boehringer Ingelheim Investigational Site 215
Sakaidechō
Boehringer Ingelheim Investigational Site 118
Sakakimachi
Boehringer Ingelheim Investigational Site 108
Sanjyo
Boehringer Ingelheim Investigational Site 41
Sano
Boehringer Ingelheim Investigational Site 1
Sapporo
Boehringer Ingelheim Investigational Site 2
Sapporo
Boehringer Ingelheim Investigational Site 3
Sapporo
Boehringer Ingelheim Investigational Site 55
Sayama
Boehringer Ingelheim Investigational Site 21
Sendai
Boehringer Ingelheim Investigational Site 115
Shikamachichō-shimoutagaura
Boehringer Ingelheim Investigational Site 210
Shimonoseki
Boehringer Ingelheim Investigational Site 19
Shiogama
Boehringer Ingelheim Investigational Site 32
Shirakawa
Boehringer Ingelheim Investigational Site 132
Shizuoka
Boehringer Ingelheim Investigational Site 133
Shizuoka
Boehringer Ingelheim Investigational Site 50
Sōka
Boehringer Ingelheim Investigational Site 174
Suita
Boehringer Ingelheim Investigational Site 147
Suzuka
Boehringer Ingelheim Investigational Site 69
Tachikawa
Boehringer Ingelheim Investigational Site 70
Tachikawa
Boehringer Ingelheim Investigational Site 71
Tachikawa
Boehringer Ingelheim Investigational Site 20
Tagajyo
Boehringer Ingelheim Investigational Site 44
Takasaki
Boehringer Ingelheim Investigational Site 45
Takasaki
Boehringer Ingelheim Investigational Site 150
Takashima
Boehringer Ingelheim Investigational Site 84
Tama
Boehringer Ingelheim Investigational Site 28
Tendō
Boehringer Ingelheim Investigational Site 109
Tōkamachi
Boehringer Ingelheim Investigational Site 213
Tokushima
Boehringer Ingelheim Investigational Site 72
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site 73
Tokyo Adachi-ku
Boehringer Ingelheim Investigational Site 74
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 75
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 79
Tokyo Chuo-ku
Boehringer Ingelheim Investigational Site 77
Tokyo Edofawa-ku
Boehringer Ingelheim Investigational Site 76
Tokyo Itabashi-ku
Boehringer Ingelheim Investigational Site 89
Tokyo Katsushika-ku
Boehringer Ingelheim Investigational Site 85
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 86
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 81
Tokyo Nerima-ku
Boehringer Ingelheim Investigational Site 82
Tokyo Nerima-ku
Boehringer Ingelheim Investigational Site 87
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site 67
Tokyo Shinjyuku-ku
Boehringer Ingelheim Investigational Site 68
Tokyo Shinjyuku-ku
Boehringer Ingelheim Investigational Site 78
Tokyo Sumida-ku
Boehringer Ingelheim Investigational Site 88
Tokyo Sumida-ku
Boehringer Ingelheim Investigational Site 80
Tokyo Toshima-ku
Boehringer Ingelheim Investigational Site 214
Tonosho-cho
Boehringer Ingelheim Investigational Site 221
Tosashimizu
Boehringer Ingelheim Investigational Site 110
Toyama
Boehringer Ingelheim Investigational Site 135
Toyohashi
Boehringer Ingelheim Investigational Site 136
Toyohashi
Boehringer Ingelheim Investigational Site 146
Tsu
Boehringer Ingelheim Investigational Site 36
Tsuchiura
Boehringer Ingelheim Investigational Site 247
Tsunocho
Boehringer Ingelheim Investigational Site 209
Ube
Boehringer Ingelheim Investigational Site 123
Ueda
Boehringer Ingelheim Investigational Site 42
Utsunomiya
Boehringer Ingelheim Investigational Site 218
Uwajima
Boehringer Ingelheim Investigational Site 251
Wadomari
Boehringer Ingelheim Investigational Site 211
Yamaguchi
Boehringer Ingelheim Investigational Site 190
Yamatokooriyama
Boehringer Ingelheim Investigational Site 222
Yame
Boehringer Ingelheim Investigational Site 93
Yokohama
Boehringer Ingelheim Investigational Site 94
Yokohama
Boehringer Ingelheim Investigational Site 95
Yokohama
Boehringer Ingelheim Investigational Site 96
Yokohama
Boehringer Ingelheim Investigational Site 97
Yokohama
Boehringer Ingelheim Investigational Site 91
Yokosuka
Boehringer Ingelheim Investigational Site 92
Yokosuka
Boehringer Ingelheim Investigational Site 54
Yokoze-machi
Boehringer Ingelheim Investigational Site 194
Yonago
Boehringer Ingelheim Investigational Site 98
Zama

Other trials in Japan

About this study

Official title: Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension

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

Conditions: Hypertension
Being tested: Micamlo
Medical subject headings: Hypertension

What participants receive

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

MicamloDrug
Telmisartan plus Amlodipine T40/A5

Study groups in NCT01353274
Study group	Role	What they receive
Patients with hypertension		Not described Receives: Drug: Micamlo

What is being measured

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

Incidence of Drug-related Adverse Events
Number of patients with drug-related adverse events
Measured: 12 months

Secondary outcomes (4)

Change From Baseline in Systolic Blood Pressure (SBP)
Change from baseline in SBP after 1, 2, 3, 6, 12 months
Measured: after 1, 2, 3, 6, 12 months
Change From Baseline in Diastolic Blood Pressure (DBP)
Change from baseline in DBP after 1, 2, 3, 6, 12 months
Measured: after 1, 2, 3, 6, 12 months
Proportion of Patients Who Achieved the Target BP
Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months
Measured: after 1, 2, 3, 6, 12 months
Proportion of Patients Who Normalised Their BP
Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months
Measured: after 1, 2, 3, 6, 12 months

Timeline

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

May 2011Aug 2013

First posted13 May 2011 (estimated)
Study startMay 2011
Primary completionAug 2013
Study completionAug 2013

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: 1,157 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01353274
Sponsor's protocol ID: 1235.38
Status last verified: Jul 2014
First submitted: 9 May 2011
Last updated: 18 Aug 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?

See locations

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension
ClinicalTrials.gov ID: NCT01353274
Acronym / sponsor ID: 1235.38
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 1,157 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 13 May 2011 (estimated)
Results: Posted 18 Aug 2014

Clinical summary

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

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

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with hypertension	–	Drug: Micamlo

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 1200

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

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
MicamloTelmisartan plus Amlodipine T40/A5	Drug	Patients with hypertension

Primary outcome

Incidence of Drug-related Adverse Events
Time frame: 12 months
Number of patients with drug-related adverse events

4 secondary outcomes

Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: after 1, 2, 3, 6, 12 months
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: after 1, 2, 3, 6, 12 months
Proportion of Patients Who Achieved the Target BP
Time frame: after 1, 2, 3, 6, 12 months
Proportion of Patients Who Normalised Their BP
Time frame: after 1, 2, 3, 6, 12 months

Results and safety

Results posted to the registry on 18 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Hypertension	1,157	1,129

Primary outcome: Incidence of Drug-related Adverse Events

Time frame: 12 months. Number. Unit: participants

Measure	Patients With Hypertension n = 1109
Value	60

Population analysed: Safety set: all patients who were documented to have taken at least one dose of T40/A5 mg FDC except for patients who had no observation documented after entry, made invalid registration or were not under the appropriate site contact

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the 12-month period under the administration of T40/A5 mg FDC, up to 95 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Hypertension	22 of 1,109 (2%)	0 of 1,109 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

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

254 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 254 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 3 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 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 254 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 18 Aug 2014). 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 Drug-related Adverse Events (time frame: 12 months). 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 NCT01353274.

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 18 Aug 2014.