HypertensionPhase 4NCT02526875
Efficacy of a Telmisartan/S-Amlodipine on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
A Phase 4 study testing Telminuvo®Tab. 40/2.5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 10 sites in South Korea.
Trial summary
To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telminuvo®Tab. 40/2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 10 sitesSouth Korea
- Study dates
- Apr 2015to Nov 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 20 years in hypertension patient
- Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening
- Treatment-Naive: Clinic Mean sitting diastolic blood pressure ≥ 100mmHg.
- Treatment-Experienced: Clinic Mean sitting diastolic blood pressure ≥ 90mmHg.
- Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
- Clinic Mean sitting diastolic blood pressure ≥ 90mmHg
- Patient who decided to participate and signed on an informed consent form willingly
Who cannot join
- Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization
- As night workers who sleep during the day and whose working hours including 00:00 to 04:00
- Secondary Hypertension
- Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months
- Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
- type 1 diabetes mellitus or Uncontrolled type 2 diabetes mellitus(HbA1c > 8.0%)
Show all 26Show fewer
- Severe or malignant retinopathy
- Abnormal laboratory test results
- Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 2
- Serum creatinine > Upper normal limit X 2
- Acute of chronic inflammatory status requiring treatment
- Need for other antihypertensive drugs during the trial
- Need for prohibited medication specified in the protocol
- A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
- Severe hypersensitivity to amlodipine or telmisartan
- History of drug or alcohol abuse within 6 months
- Surgical or medical conditions
- History of major gastrointestinal surgery
- History of active inflammatory bowel syndrome within 12 months
- Abnormal pancreatic functions
- Gastrointestinal/rectal bleeding
- Urinary tract obstruction
- Administration of other Investigational Product within 30 days
- Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- History of malignant tumor within 5 years (including leukemia and lymphoma)
- Another clinical condition in investigator's judgement
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Dong-A University Hospital
Busan, Seo-gu
Jong-Sung Park, 82-51-240-2764, thinkmed@dau.ac.kr
- Recruiting
Pusan National University Hospital
Busan, Seo-gu
Kwang-Su Cha, 82-51-240-7221, chakws1@hanmail.net
- Recruiting
Daegu Catholic University Medical Center
Dae-gu, Gyeongsangbuk-do
Young-Su Lee, 82-53-650-4797, mdleeys@cu.ac.kr
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, Gyeongsangbuk-do
Hyeong-Seop Park, 82-53-250-7473, drparkgyver@gmail.com
- Recruiting
Yeungnam University Medical Center
Daegu, Gyeongsangbuk-do
Dong-Gu Shin, 82-53-620-3843, dgshin@med.yu.ac.kr
- Recruiting
Myongji Hospital
Goyang, Gyeonggi-di
Tae-Young Choi, 82-31-810-6773, tchoicardio@gmail.com
- Recruiting
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do
Sung-Wook Kwon, 82-31-910-7041, mdksu@yahoo.co.kr
- Recruiting
Cheju Halla General Hospital
Jeju City, Jeju Special Self-Governing
Seung-Ho Kang, 82-64-740-5002, metronics@paran.com
- Recruiting
Bundang Jesaeng Hospital
Seongnam-si, Gyeonggi-do
Sung-Wook Cho, 82-31-779-0379, cswim@dmc.or.kr
- Recruiting
Korean University Guro Hospital
Seoul, Guro-gu
Jin-Won Kim, 82-2-2626-3021, kjwmm@korea.ac.kr
About this study
Official title: A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Read the detailed description
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
- Conditions
- Hypertension
- Being tested
- Telminuvo®Tab. 40/2.5mg
- Keywords
- hypertension, Telmisartan/S-Amlodipine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telminuvo®Tab. 40/2.5mgDrug
Also called Telmisartan/S-Amlodipine 40/2.5mg
per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
| Study group | Role | What they receive |
|---|---|---|
| night | Experimental | Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg Receives: Drug: Telminuvo®Tab. 40/2.5mg |
| morning | Active comparator | Telminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg Receives: Drug: Telminuvo®Tab. 40/2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Measured: Baseline and week 8
Secondary outcomes (4)
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8
- Daytime: 06:00~21:59
- Nighttime: 22:00~05:59
- Morning: 06:00~11:59
Measured: Baseline and week 8
Change from baseline in the clinic mean blood pressure at week 8.
Measured: Baseline and week 8
24hr ABPM and Clinic BP control at week 8.
<24hr ABPM>
- 24hr mean BP: 24hr mean Systolic blood pressure(SBP)<130mmHg and 24hr mean Diastolic blood pressure(DBP)<80mmHg
- Daytime BP: Daytime mean SBP<135mmHg and Daytime mean DBP<85mmHg
- Night time BP: Night time mean SBP<120mmHg and Night time mean DBP<70mmHg
<Clinic BP>
: Mean sitting systolic blood pressure<140mmHg and Mean sitting diastolic blood pressure<90mmHg
Measured: Baseline and week 8
Morning BP Surge
The morning BP surge was calculated as the morning BP minus the lowest BP. Morning BP was defined as the average BP during the first 2 h after waking. The lowest BP was defined as the average of three BP readings focused on the lowest night-time reading (that is, the lowest reading plus the readings immediately before and after)
Measured: Baseline and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Gu Shin, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526875
- Sponsor's protocol ID
- 330HT14009
- Status last verified
- Aug 2017
- First submitted
- 17 Aug 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled
- ClinicalTrials.gov ID
- NCT02526875
- Acronym / sponsor ID
- 330HT14009
- Conditions
- Hypertension
- Keywords
- hypertension, Telmisartan/S-Amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine (Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Detailed description
A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial Designed to Evaluate the Efficacy of the Timing of the Administration of a Telmisartan/S-Amlodipine(Telminuvo®Tab. 40/2.5mg) on 24-hour BP Control in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| night | Experimental | Drug: Telminuvo®Tab. 40/2.5mgTelminuvo®Tab. 40/2.5mg ,Once daily, from 6 pm to 10 pm, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg |
| morning | Active comparator | Drug: Telminuvo®Tab. 40/2.5mgTelminuvo®Tab. 40/2.5mg ,Once daily, from 6 am to 10 am, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- More than 20 years in hypertension patient
- Hypertension is satisfied with the Clinic blood pressure that was measured at the time of screening
- Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
- Patient who decided to participate and signed on an informed consent form willingly
Key exclusion criteria (26 listed)
- Clinic Mean sitting systolic blood pressure ≥ 180mmHg or Clinic Mean sitting diastolic blood pressure ≥ 115mmHg at the time of Screening and Randomization
- As night workers who sleep during the day and whose working hours including 00:00 to 04:00
- Secondary Hypertension
- Severe heart disease(Heart failure; New York Heart Association(NYHA) class 3, 4) and recent unstable angina or myocardial infarction or valvular heart disease or arrhythmia requiring treatment within the past 3 months
- Severe cerebrovascular disorders such as cerebral infarction, cerebral hemorrhage within 6 months
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 |
|---|---|---|
| Telminuvo®Tab. 40/2.5mgAlso: Telmisartan/S-Amlodipine 40/2.5mgper oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg | Drug | morning, night |
Primary outcome
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
Time frame: Baseline and week 8
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8.
4 secondary outcomes
Change from baseline in the 24hr mean daytime, nighttime, morning blood pressure by ABPM at week 8
Time frame: Baseline and week 8
Change from baseline in the clinic mean blood pressure at week 8.
Time frame: Baseline and week 8
24hr ABPM and Clinic BP control at week 8.
Time frame: Baseline and week 8
Morning BP Surge
Time frame: Baseline and week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Dong-Gu Shin principal investigator
Yeungnam University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telminuvo®Tab. 40/2.5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 10 sites 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 7 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong-Gu Shin (82-53-620-3843, dgshin@med.yu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the 24hr mean blood pressure by ambulatory blood pressure monitoring(ABPM) at week 8. (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2017.