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Trial record 65 of 228 for:    special | Japan

To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT03021265
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension

Condition or disease Intervention/treatment
Hypertension Drug: T80/A5/H12.5 FDC

Detailed Description:

Non-interventional study based on newly collected data. The study will consist of a baseline visit and follow-up visits at Week 4, 8, 12, 24, 36 and 52 for patients who have newly initiated Micatrio® Combination Tablets. The patients will be followed up until discontinuation of Micatrio® Combination Tablets treatment or the end of study.

All patients administrated Micatrio® Combination Tablets after the launch at the sites contracted with the sponsor will be registered.


Study Type : Observational
Actual Enrollment : 676 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Special Drug Use-results Survey on Long-term Use of Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg Fixed Dose Combination Tablets in Patients With Hypertension
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Group/Cohort Intervention/treatment
T80/A5/H12.5 FDC
Patients with hypertension
Drug: T80/A5/H12.5 FDC
Drug
Other Name: MICATRIO




Primary Outcome Measures :
  1. The frequency of patients with any suspected adverse drug reactions [ Time Frame: Up to 52 weeks ]
    The frequency of patients with any suspected adverse drug reactions


Secondary Outcome Measures :
  1. Change from baseline in blood pressure at Week 52 [ Time Frame: Up to 52 weeks ]
    Change from baseline in blood pressure at Week 52



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500
Criteria

Inclusion criteria:

  • Patients who are prescribed with Micatrio® Combination Tablets by the discretion of investigators based on the Japanese package insert
  • Patients who have never been treated with Micatrio® Combination Tablets before enrolment

Exclusion criteria:

Patients who are participating/planned to participate in a clinical trial


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): NCT03021265


Locations
Japan
Nippon Boehringer Ingelheim Co., Ltd
Tokyo, Japan, 4570047
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Study Chair: Rie Ikeda, +81364172200 zzCDMJP_PV_PMS@boehringer-ingelheim.com

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03021265     History of Changes
Other Study ID Numbers: 1348.6
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases