HypertensionPhase 4TENUVA-BPNCT02231788
The Efficacy of a Combination of Telmisartan/S-Amlodipine Compared With Telmisartan Monotherapy
A Phase 4 study testing Telminuvo®Tab. 40/2.5mg and Telmitrend®Tab. 80mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 11 sites in South Korea.
Trial summary
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telminuvo®Tab. 40/2.5mg and Telmitrend®Tab. 80mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 11 sitesSouth Korea
- Study dates
- Jun 2014to Mar 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- More than 19 years in hypertension patient
- Hypertension is satisfied with the Clinic blood pressure that was measured at the time of randomization
- Clinic MSSBP ≥ 140mmHg
- Clinic MSSBP ≥ 130mmHg in diabetes mellitus or chronic kidney disease
- Diabetes mellitus
- Before screening, diagnosed with diabetes mellitus being treated with oral hypoglycemic agents at least 30 days OR
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- Patients who meet the following results of laboratory tests at the time of randomization. : Fasting plasma glucose ≥ 126mg/dL
- Chronic kidney disease
- Patients who meet the following results of laboratory tests at the time of randomization.: 15mL/min/1.73m2 ≤ estimated glomerular filtration rate ≤ 60mL/min/1.73m2
- Patient who decided to participate and signed on an informed consent form willingly
Who cannot join
- Clinic MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg 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
- Abnormal laboratory test results
- Aspartate aminotransferase/Alanine aminotransferase > Upper normal limit X 3
- Serum creatinine > Upper normal limit X 4
- Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.
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- 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
- Patient who is planning for a renal transplantation during the trial
- Severe or malignant retinopathy
- Acute of chronic inflammatory status requiring treatment
- A history of cancer within five years
- A history of angioedema with ACE inhibitors or angiotensin-Ⅱ receptor blockers
- Severe hypersensitivity to amlodipine or telmisartan
- 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
- Need for other antihypertensive drugs during the trial
- Need for prohibited medication specified in the protocol
- Administration of other Investigational Product within 30 days
- History of drug or alcohol abuse within 6 months
- Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- Another clinical condition in investigator's judgement
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Kosin University Gospel Hospital
Busan, Seo-gu
Kumi cha Hospital
Gumi, Gyeongsangbuk-do
Korea University Ansan Hospital
Gyeonggi-do, Ansan-si
Jeju National University Hospital
Jeju City, Aran
Bundang Cha Hospital
Seongnam, Bundang-gu
Seoul University Bundang Hospital
Seongnam, Bundang-gu
KyungHee University Medical Center
Seoul, Dongdaemun-gu
Gangnam Severance Hospital
Seoul, Gangnam-gu
Seoul University Hospital
Seoul, Jongro-gu
National Medical Center
Seoul, Jung-gu
Hallym University Kangnam Sacred Heart Hosipital
Seoul, Yeongdeungpo-gu
About this study
Official title: A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Read the detailed description
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
- Conditions
- Hypertension
- Being tested
- Telminuvo®Tab. 40/2.5mg, Telmitrend®Tab. 80mg
- Keywords
- Telminuvo, Telmitrend, Hypertension, 24hr ABPM, 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
Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
Telmitrend®Tab. 80mgDrug
Also called Telmisartan 80mg
Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
| Study group | Role | What they receive |
|---|---|---|
| Telminuvo®Tab. 40/2.5mg | Experimental | Telminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg Receives: Drug: Telminuvo®Tab. 40/2.5mg |
| Telmitrend®Tab. 80mg | Active comparator | Telmitrend®Tab.(Telmisartan) 80mg Receives: Drug: Telmitrend®Tab. 80mg |
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.
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.
Each timepoint is as following:
- 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(MSSBP)<140mmHg and Mean sitting diastolic blood pressure(MSDBP)<90mmHg (If Hypertension with Diabetes mellitus or Chronic kidney disease: MSSBP<130mmHg and MSDBP<80mmHg)
Measured: Baseline and week 8
24hr ABPM and Clinic BP response at week 8.
<24hr ABPM> 24hr mean SBP and DBP reduction≥10mmHg
<Clinic BP> MSSBP and MSDBP≥10mmHg
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 posted4 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo-Soo Kim, Professor, Principal investigator, Seoul University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231788
- Sponsor's protocol ID
- 330HT13010
- Acronym
- TENUVA-BP
- Status last verified
- Mar 2018
- First submitted
- 1 Sep 2014
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim BJ, Cho KI, Kwon HM, Choi SM, Yoon CH, Lim SW, Joo SJ, Lee NH, Lim SY, Lim SH, Kim HS. Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study. Clin Hypertens. 2022 Mar 1;28(1):7. doi: 10.1186/s40885-021-00184-0.
PubMed 35227313
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Open-label, Phase 4 Trial to Evaluate the Efficacy of Telmisartan/S-Amlodipine(Telminuvo® Tab. 40/2.5mg) on 24-hour Ambulatory BP Control Compared With Telmisartan Monotherapy in Hypertensive Patients Inadequately Controlled by Telmisartan Monotherapy
- ClinicalTrials.gov ID
- NCT02231788
- Acronym / sponsor ID
- TENUVA-BP / 330HT13010
- Conditions
- Hypertension
- Keywords
- Telminuvo, Telmitrend, Hypertension, 24hr ABPM, Telmisartan, S-amlodipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jun 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 4 Sep 2014 (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.
The Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Detailed description
A multicenter, Prospective, Randomized, Open-label, Phase 4 Trial designed to Evaluate the Efficacy of a Fixed Dose Combination of Telmisartan/S-Amlodipine on 24-hour Ambulatory BP Control Compared with Telmisartan Monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telminuvo®Tab. 40/2.5mg | Experimental | Drug: Telminuvo®Tab. 40/2.5mgTelminuvo®Tab.(Telmisartan/S-Amlodipine) 40/2.5mg |
| Telmitrend®Tab. 80mg | Active comparator | Drug: Telmitrend®Tab. 80mgTelmitrend®Tab.(Telmisartan) 80mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- More than 19 years in hypertension patient
- 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 MSSBP ≥ 200mmHg or Clinic MSDBP ≥ 120mmHg 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
- Abnormal laboratory test results
- Secondary hypertension patient without diabetes mellitus, chronic kidney disease: coarctation of aorta, cushing's syndrome, pheochromocytoma, primary aldosteronism etc.
- 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
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 40/2.5mgTelminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg | Drug | Telminuvo®Tab. 40/2.5mg |
| Telmitrend®Tab. 80mgAlso: Telmisartan 80mgTelmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg | Drug | Telmitrend®Tab. 80mg |
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
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
24hr ABPM and Clinic BP response at week 8.
Time frame: Baseline and week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Derived from this study: PubMed 35227313Kim BJ, Cho KI, Kwon HM, Choi SM, Yoon CH, Lim SW, Joo SJ, Lee NH, Lim SY, Lim SH, Kim HS. Effect of a fixed-dose combination of Telmisartan/S-amlodipine on circadian blood pressure compared with Telmisartan monotherapy: TENUVA-BP study. Clin Hypertens. 2022 Mar 1;28(1):7. doi: 10.1186/s40885-021-00184-0.
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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.
Hyo-Soo Kim, Professor principal investigator
Seoul University Hospital
11 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 and Telmitrend®Tab. 80mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 11 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 10 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: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT02231788, which also lists 1 linked publication.
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 31 Jan 2020.