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

Tracking Information
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; (submitted: July 30, 2014)	Incidence of Drug-related Adverse Events [ Time Frame: 12 months ]; Number of patients with drug-related adverse events
Original Primary Outcome Measures; (submitted: May 12, 2011)	Causal relationship of adverse event; The Intensity of adverse event
Change History	Complete list of historical versions of study NCT01353274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: July 30, 2014)	Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: after 1, 2, 3, 6, 12 months ]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 ]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 ]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 ]Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months
Original Secondary Outcome Measures; (submitted: May 12, 2011)	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
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
Study Groups/Cohorts	Patients with hypertension; Intervention: Drug: Micamlo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: July 30, 2014)	1157
Original Estimated Enrollment; (submitted: May 12, 2011)	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: 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
Sex/Gender	Sexes Eligible for Study: All
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	Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account	Boehringer Ingelheim
Verification Date	July 2014