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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
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment
Hypertension Drug: Micamlo

Study Type : Observational
Actual Enrollment : 1157 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension
Study Start Date : May 2011
Primary Completion Date : August 2013
Study Completion Date : August 2013

Group/Cohort Intervention/treatment
Patients with hypertension Drug: Micamlo
Telmisartan plus Amlodipine T40/A5



Primary Outcome Measures :
  1. Incidence of Drug-related Adverse Events [ Time Frame: 12 months ]
    Number of patients with drug-related adverse events


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353274


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01353274     History of Changes
Other Study ID Numbers: 1235.38
First Posted: May 13, 2011    Key Record Dates
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases