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Trial record 63 of 960 for:    tablet | Japan

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03021265
Recruitment Status : Completed
First Posted : January 13, 2017
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date January 12, 2017
First Posted Date January 13, 2017
Last Update Posted Date April 25, 2019
Actual Study Start Date January 20, 2017
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2017)
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
Original Primary Outcome Measures
 (submitted: January 12, 2017)
The frequency of patients with any suspected adverse drug reactions [ Time Frame: Up to 52 weeks ]
Change History Complete list of historical versions of study NCT03021265 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 13, 2017)
Change from baseline in blood pressure at Week 52 [ Time Frame: Up to 52 weeks ]
Change from baseline in blood pressure at Week 52
Original Secondary Outcome Measures
 (submitted: January 12, 2017)
Change from baseline in blood pressure at Week 52 [ Time Frame: Up to 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title To Evaluate Real-world Safety, Effectiveness and Appropriate Use of Micatrio® Combination Tablets Treatment in Patients With Hypertension
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
Brief Summary Study to evaluate real-world safety, effectiveness and appropriate use of Micatrio® Combination Tablets treatment in patients with hypertension
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 500
Condition Hypertension
Intervention Drug: T80/A5/H12.5 FDC
Drug
Other Name: MICATRIO
Study Groups/Cohorts T80/A5/H12.5 FDC
Patients with hypertension
Intervention: Drug: T80/A5/H12.5 FDC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 16, 2018)
676
Original Estimated Enrollment
 (submitted: January 12, 2017)
650
Actual Study Completion Date April 11, 2019
Actual Primary Completion Date April 11, 2019   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03021265
Other Study ID Numbers 1348.6
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Study Chair: Rie Ikeda, +81364172200 zzCDMJP_PV_PMS@boehringer-ingelheim.com
PRS Account Boehringer Ingelheim
Verification Date April 2019