Trial Outcomes & Findings for 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 (NCT NCT01243268)

Results Overview

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)

Recruitment status

COMPLETED

Target enrollment

674 participants

Primary outcome timeframe

Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)

Results posted on

2018-10-22

Participant Flow

Case report forms of subjects were retrieved from 34 investigators at 26 institutions

The study initiated on Dec 21, 2010, but the local health authority fixed the study period as August 19, 2010 to August 18, 2016

Participant milestones

Participant milestones
Measure	Twynsta® Tablets Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Overall Study STARTED	674
Overall Study COMPLETED	610
Overall Study NOT COMPLETED	64

Reasons for withdrawal

Reasons for withdrawal
Measure	Twynsta® Tablets Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Overall Study Lost to Follow-up	4
Overall Study Protocol Violation	51
Overall Study Deviation with contract date	7
Overall Study Duplicate subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Twynsta® Tablets n=610 Participants Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Age, Continuous	61.96 years STANDARD_DEVIATION 12.43 • n=93 Participants
Sex: Female, Male Female	271 Participants n=93 Participants
Sex: Female, Male Male	339 Participants n=93 Participants

PRIMARY outcome

Timeframe: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)

Population: Subjects data collected during the surveillance period (19 Aug 2010 to 18 Aug 2016).

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)

Outcome measures

Outcome measures
Measure	Twynsta® Tablets n=610 Participants Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Percentage of Subjects With Adverse Events Long term surveillance	3.80 percentage of participants Interval 0.79 to 10.7
Percentage of Subjects With Adverse Events Short term surveillance	3.28 percentage of participants Interval 1.43 to 6.36

SECONDARY outcome

Timeframe: 8±2 weeks

Population: An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)

Percentage of subjects who had achieved normal blood pressure (SBP/DBP \< 140/90 millimeters of mercury (mmHg))is presented

Outcome measures

Outcome measures
Measure	Twynsta® Tablets n=531 Participants Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)	74.95 percentage of participants Interval 71.04 to 78.58

SECONDARY outcome

Timeframe: 8±2 weeks

Population: An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)

Percentage of subjects who achieved DBP response (defined as mean sitting DBP \< 90 mmHg or a reduction of over 10 mmHg) is presented

Outcome measures

Outcome measures
Measure	Twynsta® Tablets n=531 Participants Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)	89.45 percentage of participants Interval 86.52 to 91.93

SECONDARY outcome

Timeframe: 8±2 weeks

Population: An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)

Percentage of subjects who achieved SBP response (defined as mean sitting SBP \< 140 mmHg or a reduction of over 10 mmHg) is presented

Outcome measures

Outcome measures
Measure	Twynsta® Tablets n=531 Participants Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)	87.76 percentage of participants Interval 84.67 to 90.42

SECONDARY outcome

Timeframe: 8±2 weeks

Population: An efficacy assessment was carried out for 531 subjects out of the 610 subjects in the safety assessment, excluding 70 subjects who had not recorded the mean sitting blood pressure (SBP, DBP) before or after the administration of the study drug and 9 subjects who had been administered the study drug for a duration shorter than 6 weeks (42 days)

Percentage of subjects with diabetes or renal impairment who achieved SBP/DBP \< 130/80 mmHg is presented

Outcome measures

Outcome measures
Measure	Twynsta® Tablets n=531 Participants Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.	39.53 percentage of participants Interval 31.04 to 48.52

Adverse Events

Twynsta® Tablets

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Twynsta® Tablets n=610 participants at risk Subjects who received Twynsta tablets (40/5 mg, 40/10 mg, and 80/5 mg) once daily orally with water. Twynsta is a fixed dose combination drug composed of Telmisartan and Amlodipine.
Nervous system disorders Cerebral infarction	0.16% 1/610 • Adverse events collected during the surveillance period (19 Aug 2010 to 18 Aug 2016); up to 313 weeks
Cardiac disorders Cardiac failure congestive	0.16% 1/610 • Adverse events collected during the surveillance period (19 Aug 2010 to 18 Aug 2016); up to 313 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.16% 1/610 • Adverse events collected during the surveillance period (19 Aug 2010 to 18 Aug 2016); up to 313 weeks

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER