Essential HypertensionPhase 3NCT02738632
Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients
A Phase 3 study testing Telmisartan/Amlodipine+Hydrochlorothiazide and Telmisartan/Amlodipine in people with Essential Hypertension, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.
Trial summary
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Telmisartan/Amlodipine+Hydrochlorothiazide and Telmisartan/Amlodipine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Aug 2016
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years old or above Koreans living in Korea
- Patients with uncontrolled essential hypertension at screening time(Visit 1)
- Naïve: 160 mmHg ≤ sitSBP < 200 mmHg
- Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
- Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)
- 140 mmHg ≤ sitSBP < 200 mmHg
- Patients who agreed to participate in the trial
Who cannot join
- Test results showing the following values at screening time(Visit 1)
- The change of mean sitSBP ≥ 20 mmHg or sitDBP ≥ 10 mmHg on target arm between 1st and 2nd measurement
- screening time(Visit 1), time of randomization(Visit 2): sitDBP ≥ 120 mmHg
- Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
- -Patients with congestive heart failure(NYHA class III~IV)
- Patients with unstable angina or myocardial infarction or valvular heart disease within 6 months prior to study entry
Show all 26Show fewer
- Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
- Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
- Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%
- Patients who have history of severe or malignant retinopathy within 6 months prior to study entry
- Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT > 2.5 times of upper limit of normal range)
- Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators)
- Patients who should be administered medications prohibited for concomitant use during study period
- Patients who are dependent on drugs or alcohol
- Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion
- Patients with hypersensitivity to the components of investigational drug.
- Patients with hypersensitivity to Sulfonamide
- Patients with anuria
- Patients with hypercalcemia, hyponatremia/hypokalemia
- Patients with Addison's disease
- Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy
- History of malignant tumor including leukemia, lymphoma within 5 years
- Patients taking other clinical trial drugs within 30 days from the time of visit for screening
- Pregnancy, breast-feeding, or child-bearing potential Patients
- Patients who are judged unsuitable to participate in this study by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients Not Controlled by Telmisartan/Amlodipine Combination
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination
- Conditions
- Essential Hypertension
- Being tested
- Telmisartan/Amlodipine+Hydrochlorothiazide, Telmisartan/Amlodipine, Placebo for Hydrochlorothiazide
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan/Amlodipine+HydrochlorothiazideDrug
Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD
Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD
Telmisartan/AmlodipineDrug
Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD
Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD
Placebo for HydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan/Amlodipine+Hydrochlorothiazide | Experimental | Telmisartan/Amlodipine combination drug and Hydrochlorothiazide Receives: Drug: Telmisartan/Amlodipine+Hydrochlorothiazide |
| Telmisartan/Amlodipine | Active comparator | Telmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide Receives: Drug: Telmisartan/Amlodipine; Drug: Placebo for Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of sitting systolic blood pressure
Measured: From baseline at week 8
Secondary outcomes (4)
The change of sitting systolic blood pressure
Measured: From baseline at week 2
The change of sitting diastolic blood pressure
Measured: From baseline at week 2 and 8
The ratio of subjects who get normalized blood pressure
Measured: at week 2 and 8
Response Rate
Measured: at week 2 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionAug 2016
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 Essential HypertensionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738632
- Sponsor's protocol ID
- ID-TAH-301
- Status last verified
- Jan 2016
- First submitted
- 11 Apr 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sung KC, Oh YS, Cha DH, Hong SJ, Won KH, Yoo KD, Rha SW, Ahn YK, Ahn JC, Jang JY, Hong TJ, Cho SK, Park SH, Hyon MS, Nam CW, Chae IH, Yoo BS, Song JM, Jeong JO, Yoon YW, Kim BS, Yang TH, Cho DK, Kim SH, Choi YJ, Ahn JH, Jeon DW, Kim HS. Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study. Clin Ther. 2018 Jan;40(1):50-63.e3. doi: 10.1016/j.clinthera.2017.11.006. Epub 2017 Dec 14.
PubMed 29248384
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients Not Controlled by Telmisartan/Amlodipine Combination
- ClinicalTrials.gov ID
- NCT02738632
- Acronym / sponsor ID
- ID-TAH-301
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Apr 2016 (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.
Randomized, Double-Blind, Multi-Center, Phase 3 Trial to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Hydrochlorothiazide Combination in Comparison with Telmisartan/Amlodipine Combination for Essential Hypertension Patients not Controlled by Telmisartan/Amlodipine Combination
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan/Amlodipine+Hydrochlorothiazide | Experimental | Drug: Telmisartan/Amlodipine+HydrochlorothiazideTelmisartan/Amlodipine combination drug and Hydrochlorothiazide |
| Telmisartan/Amlodipine | Active comparator | Drug: Telmisartan/Amlodipine, Drug: Placebo for HydrochlorothiazideTelmisartan/Amlodipine combination drug and Placebo for Hydrochlorothiazide |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 19 years old or above Koreans living in Korea
- Patients with uncontrolled essential hypertension at screening time(Visit 1)
- Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)
- Patients who agreed to participate in the trial
Key exclusion criteria (26 listed)
- Test results showing the following values at screening time(Visit 1)
- Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
- -Patients with congestive heart failure(NYHA class III~IV)
- Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
- Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%
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 |
|---|---|---|
| Telmisartan/Amlodipine+HydrochlorothiazideTreatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD | Drug | Telmisartan/Amlodipine+Hydrochlorothiazide |
| Telmisartan/AmlodipineTreatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD | Drug | Telmisartan/Amlodipine |
| Placebo for Hydrochlorothiazide | Drug | Telmisartan/Amlodipine |
Primary outcome
The change of sitting systolic blood pressure
Time frame: From baseline at week 8
4 secondary outcomes
The change of sitting systolic blood pressure
Time frame: From baseline at week 2
The change of sitting diastolic blood pressure
Time frame: From baseline at week 2 and 8
The ratio of subjects who get normalized blood pressure
Time frame: at week 2 and 8
Response Rate
Time frame: at week 2 and 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 25 Nov 2016.
- Derived from this study: PubMed 29248384Sung KC, Oh YS, Cha DH, Hong SJ, Won KH, Yoo KD, Rha SW, Ahn YK, Ahn JC, Jang JY, Hong TJ, Cho SK, Park SH, Hyon MS, Nam CW, Chae IH, Yoo BS, Song JM, Jeong JO, Yoon YW, Kim BS, Yang TH, Cho DK, Kim SH, Choi YJ, Ahn JH, Jeon DW, Kim HS. Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study. Clin Ther. 2018 Jan;40(1):50-63.e3. doi: 10.1016/j.clinthera.2017.11.006. Epub 2017 Dec 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Telmisartan/Amlodipine+Hydrochlorothiazide and Telmisartan/Amlodipine in people with Essential Hypertension, run by IlDong Pharmaceutical Co Ltd 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 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: finished, as of the sponsor's last update on 25 Nov 2016. 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?
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?
The change of sitting systolic blood pressure (time frame: From baseline at 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 NCT02738632, 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 25 Nov 2016.