HypertensionPhase 3NCT01983735
Efficacy and Safety of TELMINUVO to Stage 2 Hypertension
A Phase 3 study testing TELMINUVO Tab. (80/2.5mg), TELMINUVO Tab. (80/5mg) and S-amlodipine 2.5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- TELMINUVO Tab. (80/2.5mg), TELMINUVO Tab. (80/5mg) and S-amlodipine 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Aug 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- at the screening visit
- antihypertensive drugs not taking: 160mmHg ≤ sitSBP < 200mmHg
- antihypertensive drugs taking: 140mmHg ≤ sitSBP < 180mmHg
- at the randomization visit(160mmHg ≤ sitSBP < 200mmHg)
- willing and able to provide written informed consent
Who cannot join
- mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
- for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
- has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months
- Type I Diabetes Mellitus, Type II Diabetes Mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(HbA1c) > 8%)
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- known severe or malignant retinopathy
- defined by the following laboratory parameters:
- hepatic dysfunction(AST/ALT > UNL X 3)
- renal dysfunction(serum creatinine > UNL X 1.5)
- hypopotassemia(K < 3.0mmol/L) or hyperpotassemia (K>5.5 mmol/L)
- acute or chronic inflammatory status need to treatment
- need to additional antihypertensive drugs during the study
- need to concomitant medications known to affect blood pressure during the study
- history of angioedema related to ACE inhibitors or Angiotensin II Receptor Blockers
- known hypersensitivity related to either study drug
- history of drug or alcohol dependency within 6 months
- any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding)
- administration of other study drugs within 4weeks prior to screening
- premenopausal women(last menstruation > 1year) not using adequate contraception, pregnant or breast-feeding
- history of malignancy including leukemia and lymphoma within the past 5 years
- in investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The catholic university of Korea Seoul St. Mary's hospital
Seoul
Ho-Joong Yoon, Ph.D, 82-2-2258-6029, younhj@catholic.ac.kr
Ho-Joong Yoon, Ph.D
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension
The aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.
Read the detailed description
- In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks.
- This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(8 weeks_double blind).
- Conditions
- Hypertension
- Being tested
- TELMINUVO Tab. (80/2.5mg), TELMINUVO Tab. (80/5mg), S-amlodipine 2.5mg, S-amlodipine 5mg
- Keywords
- TELMINUVO Tab., CKD-828, Hypertension, Stage 2 Hypertension, S-Amlodipine, Telmisartan
- 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. (80/2.5mg)Drug
Also called TELMINUVO Tab.
- Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks.
- With the others investigation product placebo 1 tab QD 2 weeks.
TELMINUVO Tab. (80/5mg)Drug
Also called TELMINUVO Tab.
- Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks.
- With the others investigation product placebo 1 tab QD 6 weeks.
S-amlodipine 2.5mgDrug
Also called Anydipine S
- S-amlodipine 2.5mg QD 2 weeks
- With the others investigation product placebo 1 tab QD 2 weeks.
S-amlodipine 5mgDrug
Also called Anydipine S
- S-amlodipine 5mg QD 6weeks
- With the others investigation product placebo 1 tab QD 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TELMINUVO Tab. (80/2.5mg, 80/5mg) | Experimental | Not described Receives: Drug: TELMINUVO Tab. (80/2.5mg); Drug: TELMINUVO Tab. (80/5mg) |
| S-Amlodipine 2.5, 5mg | Active comparator | Not described Receives: Drug: S-amlodipine 2.5mg; Drug: S-amlodipine 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Sitting Systolic Blood Pressure (MSSBP)
Measured: After 8 weeks of treatment
Secondary outcomes (4)
Mean Sitting Systolic Blood Pressure (MSSBP)
Measured: After 2 weeks and 4 weeks of treatment
Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: After 2weeks, 4weeks and 8 weeks of treatment
Control Rate
Sitting SBP<140mmHg, Sitting DBP<90mmHg
Measured: After 8 weeks of treatment
Response Rate
Reduction of Sitting SBP≥20mmHg, Sitting DBP ≥10mmHg
Measured: After 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983735
- Sponsor's protocol ID
- 130HT13015
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Telmisartan and S-Amlodipine(TELMINUVO TAB.) Versus S-Amlodipine Monotherapy in Patients With Stage 2 Hypertension
- ClinicalTrials.gov ID
- NCT01983735
- Acronym / sponsor ID
- 130HT13015
- Conditions
- Hypertension
- Keywords
- TELMINUVO Tab., CKD-828, Hypertension, Stage 2 Hypertension, S-Amlodipine, Telmisartan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 14 Nov 2013 (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 aim of present study is to evaluate the efficacy and safety of two dose combination of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) compared with S-Amlodipine monotherapy (2.5mg and 5mg) in patients with Stage 2 hypertension.
Detailed description
- In patients with Stage 2 hypertension to determine the efficacy and safety of Telmisartan/S-Amlodipine (80/2.5mg and 80/5mg) or S-Amlodipine monotherapy (2.5mg and 5mg) during 8 weeks.
- This study is consist of placebo run-in period(2 weeks_single blind) and treatment period(8 weeks_double blind).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TELMINUVO Tab. (80/2.5mg, 80/5mg) | Experimental | Drug: TELMINUVO Tab. (80/2.5mg), Drug: TELMINUVO Tab. (80/5mg) |
| S-Amlodipine 2.5, 5mg | Active comparator | Drug: S-amlodipine 2.5mg, Drug: S-amlodipine 5mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18 years or older
- at the screening visit
- at the randomization visit(160mmHg ≤ sitSBP < 200mmHg)
- willing and able to provide written informed consent
Key exclusion criteria (22 listed)
- mean sitting DBP ≥ 120mmHg or mean sitting SBP ≥ 200mmHg at the screening visit and randomization visit
- for the past four weeks based on beginning of administration, patients took over four antihypertensive drugs
- known or suspected secondary hypertension(ex. aortic coarctation, Primary hyperaldosteronism, renal artery stenosis, pheochromocytoma)
- has severe heart disease(Heart failure NYHA functional class 3, 4), ischaemic heart diseases status need to treatment, myocardiopathy, Valve disease, arrhythmia and so on and operated Coronary angioplasty
- has cerebrovascular disease 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. (80/2.5mg)Also: TELMINUVO Tab.* Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks. * With the others investigation product placebo 1 tab QD 2 weeks. | Drug | TELMINUVO Tab. (80/2.5mg, 80/5mg) |
| TELMINUVO Tab. (80/5mg)Also: TELMINUVO Tab.* Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks. * With the others investigation product placebo 1 tab QD 6 weeks. | Drug | TELMINUVO Tab. (80/2.5mg, 80/5mg) |
| S-amlodipine 2.5mgAlso: Anydipine S* S-amlodipine 2.5mg QD 2 weeks * With the others investigation product placebo 1 tab QD 2 weeks. | Drug | S-Amlodipine 2.5, 5mg |
| S-amlodipine 5mgAlso: Anydipine S* S-amlodipine 5mg QD 6weeks * With the others investigation product placebo 1 tab QD 6 weeks. | Drug | S-Amlodipine 2.5, 5mg |
Primary outcome
Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: After 8 weeks of treatment
4 secondary outcomes
Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: After 2 weeks and 4 weeks of treatment
Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: After 2weeks, 4weeks and 8 weeks of treatment
Control Rate
Time frame: After 8 weeks of treatment
Response Rate
Time frame: After 8 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TELMINUVO Tab. (80/2.5mg), TELMINUVO Tab. (80/5mg) and S-amlodipine 2.5mg in people with Hypertension, run by Chong Kun Dang Pharmaceutical 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 6 inclusion and 22 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 14 Nov 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ho-Joong Yoon, Ph.D (82-2-2258-6029, younhj@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Sitting Systolic Blood Pressure (MSSBP) (time frame: After 8 weeks of treatment). 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 14 Nov 2013.