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

Completed

• Conditions: Hypertension
• Interventions: Drug: Twynsta tablet

• Registration Number: NCT01243268
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Study Design:

PMS Observational study

Study Timeline

• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-17
• Study First Posted: 2010-11-18
• Study Start: 2010-12-21
• Primary Completion: 2016-06-27
• Study Completion: 2016-08-18
• Results First Submitted: 2017-06-23
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-14
• Last Update Submitted: 2017-12-14
• Results First Posted: 2018-10-22
• Last Update Posted: 2018-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 674

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with essential hypertension	Twynsta tablet	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Adverse Events	Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)	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)

Secondary Outcome Measures

Name	Time	Method
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 had achieved normal blood pressure (SBP/DBP \< 140/90 millimeters of mercury (mmHg))is presented
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 who achieved SBP response (defined as mean sitting SBP \< 140 mmHg or a reduction of over 10 mmHg) is presented
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 DBP response (defined as mean sitting DBP \< 90 mmHg or a reduction of over 10 mmHg) is presented
Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.	8±2 weeks	Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP \< 130/80 mmHg is presented

Trial Locations

Locations (1)

NISND Center; 🇰🇷 One Or Multiple Sites, Korea, Republic of