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OpenTrials
Completed

NCT Number: NCT01353274

Safety and Efficacy of Daily 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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim Investigational Site 199, Akaiwa, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micamlo

Drug

Telmisartan plus Amlodipine T40/A5

Primary outcomes

  1. Incidence of Drug-related Adverse Events

    Time frame: 12 months

    Number of patients with drug-related adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 13, 2011
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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