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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01353274
First received: May 9, 2011
Last updated: July 30, 2014
Last verified: July 2014
History of Changes

May 9, 2011
July 30, 2014
May 2011
August 2013   (final data collection date for primary outcome measure)
Incidence of Drug-related Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of patients with drug-related adverse events
  • Causal relationship of adverse event [ Designated as safety issue: Yes ]
  • The Intensity of adverse event [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01353274 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Systolic Blood Pressure (SBP) [ Time Frame: after 1, 2, 3, 6, 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months
The changes between baseline and observation period in blood pressure [ Designated as safety issue: No ]
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Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension
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
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample
1200
Hypertension
Drug: Micamlo
Telmisartan plus Amlodipine T40/A5
Patients with hypertension
Intervention: Drug: Micamlo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1157
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01353274
1235.38
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP