Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension
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ClinicalTrials.gov Identifier: NCT01353274 |
Recruitment Status
:
Completed
First Posted
: May 13, 2011
Results First Posted
: August 18, 2014
Last Update Posted
: August 18, 2014
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Tracking Information | ||||
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First Submitted Date | May 9, 2011 | |||
First Posted Date | May 13, 2011 | |||
Results First Submitted Date | July 30, 2014 | |||
Results First Posted Date | August 18, 2014 | |||
Last Update Posted Date | August 18, 2014 | |||
Study Start Date | May 2011 | |||
Actual Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Incidence of Drug-related Adverse Events [ Time Frame: 12 months ] Number of patients with drug-related adverse events
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT01353274 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
The changes between baseline and observation period in blood pressure | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension | |||
Official Title | Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension | |||
Brief Summary | Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | 1200 | |||
Condition | Hypertension | |||
Intervention | Drug: Micamlo
Telmisartan plus Amlodipine T40/A5 |
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Study Groups/Cohorts | Patients with hypertension
Intervention: Drug: Micamlo |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1157 | |||
Original Estimated Enrollment |
1000 | |||
Actual Study Completion Date | August 2013 | |||
Actual Primary Completion Date | August 2013 (Final data collection date for primary outcome measure) | |||
Eligibility 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:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01353274 | |||
Other Study ID Numbers | 1235.38 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Boehringer Ingelheim | |||
Study Sponsor | Boehringer Ingelheim | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | July 2014 |