A Regulatory Requirement Post-Marketing Surveillance Study to Monitor the Safety and Efficacy of Twynsta (Telmisartan + Amlodipine SPC, q.d.) in Korean Hypertensive Patients Requiring Combination Therapy
1 other identifier
observational
674
1 country
1
Brief Summary
This is a prospective, observational, open-label, multi-center study, which will provide detailed information about the safety and efficacy of Twynsta tablets in Korean hypertensive patients requiring combination therapy. This will present a convenient treatment option for hypertension in Korean patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2010
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2010
CompletedFirst Posted
Study publicly available on registry
November 18, 2010
CompletedStudy Start
First participant enrolled
December 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2016
CompletedResults Posted
Study results publicly available
October 22, 2018
CompletedOctober 22, 2018
December 1, 2017
5.5 years
November 17, 2010
June 23, 2017
December 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects With Adverse Events
Percentage of subjects with adverse events is presented. Results are reported for short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)
Secondary Outcomes (4)
Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)
8±2 weeks
Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)
8±2 weeks
Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)
8±2 weeks
Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.
8±2 weeks
Study Arms (1)
Patients with essential hypertension
Interventions
Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10
Eligibility Criteria
Korean patients wtih essential hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NISND Center
One Or Multiple Sites, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2010
First Posted
November 18, 2010
Study Start
December 21, 2010
Primary Completion
June 27, 2016
Study Completion
August 18, 2016
Last Updated
October 22, 2018
Results First Posted
October 22, 2018
Record last verified: 2017-12