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: January 15, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Hypertension
Drug: Micamlo

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of patients with adverse drug reaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients who have achieved the target blood pressure (BP) [ Time Frame: after 1, 2, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Proportion of patients who have normalised their BP [ Time Frame: after 1, 2, 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) [ Time Frame: after 1, 2, 3, 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 1129
Study Start Date: May 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with hypertension Drug: Micamlo
Telmiartan plus Amlodipine T40/A5

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

1200

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353274

  Show 254 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01353274     History of Changes
Other Study ID Numbers: 1235.38
Study First Received: May 9, 2011
Last Updated: January 15, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014