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

An observational study of Hypertension, run by Boehringer Ingelheim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Hypertension
What is being tested?: Twynsta tablet
Type of treatment: Pill or oral medicine
How many people: 674 participants
Where: 1 siteSouth Korea
Study dates: 21 Dec 2010to 18 Aug 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Korean patients wtih essential hypertension

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

NISND Center
One Or Multiple Sites

Other trials in South Korea

About this study

Read the detailed description

Study Design:

PMS Observational study

Conditions: Hypertension
Being tested: Twynsta tablet
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Twynsta tabletDrug
Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10

Study groups in NCT01243268
Study group	Role	What they receive
Patients with essential hypertension		Not described Receives: Drug: Twynsta tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Dec 201018 Aug 2016

First posted18 Nov 2010 (estimated)
Study start21 Dec 2010
Primary completion27 Jun 2016
Study completion18 Aug 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 674 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01243268
Sponsor's protocol ID: 1235.40
Status last verified: Dec 2017
First submitted: 17 Nov 2010
Last updated: 22 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01243268
Acronym / sponsor ID: 1235.40
Conditions: Hypertension
Study type: Observational
Recruitment status: Completed
Enrolment: 674 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 21 Dec 2010 (actual)
Primary completion: 27 Jun 2016 (actual)
Study completion: 18 Aug 2016 (actual)
First posted: 18 Nov 2010 (estimated)
Results: Posted 22 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study Design:

PMS Observational study

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with essential hypertension	–	Drug: Twynsta tablet

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Korean patients wtih essential hypertension

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Twynsta tabletTelmisartan and Amlodipine T40/A5, T80/A5 and T40/A10	Drug	Patients with essential hypertension

Primary outcome

Percentage of Subjects With Adverse Events
Time frame: 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)

4 secondary outcomes

Percentage of Subjects Who Had Achieved Normal Blood Pressure (Systolic Blood Pressure (SBP)/ Diastolic Blood Pressure (DBP) < 140/90 mmHg)
Time frame: 8±2 weeks
Percentage of Subjects Who Achieved DBP Response (Defined as Mean Sitting DBP < 90 mmHg or a Reduction of Over 10 mmHg)
Time frame: 8±2 weeks
Percentage of Subjects Who Achieved SBP Response (Defined as Mean Sitting SBP < 140 mmHg or a Reduction of Over 10 mmHg)
Time frame: 8±2 weeks
Percentage of Subjects With Diabetes or Renal Impairment Who Achieved SBP/DBP < 130/80 mmHg.
Time frame: 8±2 weeks

Results and safety

Results posted to the registry on 22 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Twynsta® Tablets	674	610

Primary outcome: Percentage of Subjects With Adverse Events

Time frame: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Twynsta® Tablets n = 610
Short term surveillance	3.28 (1.43 to 6.36)
Long term surveillance	3.80 (0.79 to 10.70)

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

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events collected during the surveillance period (19 Aug 2010 to 18 Aug 2016); up to 313 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Twynsta® Tablets	3 of 610 (0.5%)	0 of 610 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Boehringer Ingelheim at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With Adverse Events (time frame: Short term surveillance (8±2 weeks) and Long term surveillance (16±2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01243268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.