Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 60 of 71 for:    TELMISARTAN AND HYDROCHLOROTHIAZIDE

Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

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: NCT01050062
Recruitment Status : Completed
First Posted : January 15, 2010
Results First Posted : January 30, 2013
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date December 24, 2009
First Posted Date January 15, 2010
Results First Submitted Date December 18, 2012
Results First Posted Date January 30, 2013
Last Update Posted Date May 1, 2014
Study Start Date January 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 18, 2012)
Incidence of Adverse Events (AEs) [ Time Frame: Week 52 ]
The number of patient with any AEs, patients with drug-related AEs
Original Primary Outcome Measures
 (submitted: January 14, 2010)
The primary end point is to confirm safety (Adverse event) and antihypertensive effect on the long term use in daily clinical settings. [ Time Frame: 12months ]
Change History Complete list of historical versions of study NCT01050062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 4, 2014)
  • Systolic Blood Pressure (SBP) [ Time Frame: Week 0 and Week 52 ]
    SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated.
  • Diastolic Blood Pressure (DBP) [ Time Frame: Week 0 and Week 52 ]
    DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated.
  • Target Blood Pressure Achievement Rate [ Time Frame: Week 52 ]
    The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient.
  • Blood Pressure Normalised Rate [ Time Frame: Week 52 ]
    The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use
Official Title Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension
Brief Summary The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 1000
Condition Hypertension
Intervention
  • Drug: Telmisartan 80mg
    Combination tablet
  • Drug: Telmisartan 40mg
    Combination tablet
  • Drug: Hydrochlorothiazide 12.5mg
    Combination tablet
Study Groups/Cohorts
  • Micombi® Combination Tablet AP
    Interventions:
    • Drug: Telmisartan 40mg
    • Drug: Hydrochlorothiazide 12.5mg
  • Micombi® Combination Tablet BP
    Interventions:
    • Drug: Telmisartan 80mg
    • Drug: Hydrochlorothiazide 12.5mg
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: December 18, 2012)
1452
Original Estimated Enrollment
 (submitted: January 14, 2010)
1000
Actual Study Completion Date December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

Hypertensive patients who have never taken Micombi Tablets.

Exclusion criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 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 NCT01050062
Other Study ID Numbers 502.542
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor Boehringer Ingelheim
Collaborators Astellas Pharma Inc
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date April 2014