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
  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:
  • Incidence of Drug-related Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients with drug-related adverse events


Secondary Outcome Measures:
  • 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


Enrollment: 1157
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
Telmisartan 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: July 30, 2014
Last Updated: July 30, 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 August 21, 2014