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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01243268
First received: November 17, 2010
Last updated: June 25, 2014
Last verified: June 2014

November 17, 2010
June 25, 2014
December 2010
August 2016   (final data collection date for primary outcome measure)
  • Safety endpoint All adverse events in patients who take at least one dose of Twynsta tablets will be noted [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Safety endpoint All adverse events in patients who take at least one does of Twynsta tablets will be noted [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01243268 on ClinicalTrials.gov Archive Site
  • Efficacy endpoint Percentage of patients achieving normal blood pressure (SBP/DBP < 140/90mmHg) [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving normal blood pressure (SBP/DBP < 140/90mmHg) [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving DBP response (defined as mean seated DBP < 90mmHg or a drop of more than 10mmHg) [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving DBP response (defined as mean seated DBP < 90mmHg or a drop of more than 10mmHg) [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving SBP response (defined as mean seated SBP < 140mmHg or a drop of more than 10mmHg) [ Time Frame: 8+/-2weeks ] [ Designated as safety issue: No ]
  • Efficacy endpoint Percentage of patients achieving SBP response (defined as mean seated SBP < 140mmHg or a drop of more than 10mmHg) [ Time Frame: 16+/-2weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Study Design:

PMS Observational study

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Korean patients wtih essential hypertension

Hypertension
Drug: Twynsta tablet
Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10
Patients with essential hypertension
Intervention: Drug: Twynsta tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
August 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

Exclusion criteria:

No specific inclusion and exclusion criteria will be provided due to the exploratory character of the study. Patients who have initiated Twynsta tablets according to the recommended and approved usage in Korea will be consecutively enrolled.

Both
19 Years and older
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Korea, Republic of
 
NCT01243268
1235.40
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP