Essential HypertensionPhase 4NCT03226340
S-amlodipine+Chlorthalidone vs S-amlodipine+Telmisartan in Hypertension
A Phase 4 study testing S-amlodipine 2.5mg + Chlorthalidone 25mg and S-amlodipine 2.5mg + Telmisartan 40mg in people with Essential Hypertension, run by Seoul National University Bundang Hospital at 10 sites in South Korea.
Trial summary
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With CCB(Calcium Channel Blocker) Monotherapy Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- S-amlodipine 2.5mg + Chlorthalidone 25mg and S-amlodipine 2.5mg + Telmisartan 40mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 2 Dec 2015to 31 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women with essential hypertension who were aged 19 years or older and younger than 80 years
- Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening)
- Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg
- Those who have voluntarily agreed in writing to participate in the trial
Who cannot join
- Patients with a history of secondary hypertension and all those with suspected secondary hypertension (including, but not limited to, coarctation of the aorta, primary aldosteronism, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.)
- Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1.
- When the blood pressure was measured three times in the reference arm of visit 1 (screening), the difference between the highest lowest sit SBP was 20 mmHg or higher and the difference between the highest lowest sit DBP was 10 mmHg or higher.
- An uncontrolled diabetic patient(HbA1c≥9.0%)
- In addition to antihypertensive drugs, drugs that may affect blood pressure( Systemic steroids, Thyroid hormones, Oral contraceptives, antipsychotic drugs, NSAIDs, sympathomimetics, immunosuppressants, etc.) have been continuously administered for more than 12 weeks prior to visit 1 (screening)
- Patients who are expected to take antihypertensive drugs other than clinical drugs during the trial
Show all 26Show fewer
- Patients with orthostatic hypotension with symptoms
- Patients with a history of malignant tumors including leukemia and lymphoma within the past 5 years
- Patients with a history of autoimmune diseases such as chronic joint rheumatism and systemic lupus erythematosus
- Those who have a history of hypersensitivity to the amlodipine nicotinate or other chlortalidone or telmisartan drug
- Patients with clinically significant renal • hepatic disease such as those on dialysis, cirrhosis, biliary obstruction, hepatic failure, or those who have the following findings on visit 1 (screening)
- ALanine Transaminase or ASpartate Transaminase is more than 3 times the normal upper limit
- Total bilirubin more than twice the normal upper limit
- More than twice the Blood Urea Nitrogen normal upper limit
- Alkaline Phosphatase More than twice the normal upper limit - Creatinine Clearance Less than 10 mL / min
- Within the last 6 months, patients who have received the following diseases or treatments and whose clinical judgment is meaningful to the researcher
- Severe heart disease (heart failure New York Heart Association class III and IV), ischemic heart disease, peripheral vascular disease, hemodynamically significant valve stenosis, arrhythmia, etc
- Patients with severe cerebrovascular disorders (stroke, cerebral infarction, cerebral hemorrhage, etc.)
- Shock patient
- Patients with clinical history of alcohol or substance abuse
- Patients with potential pregnancy or breastfeeding
- In the case of pregnant women, if the negative is not confirmed during pregnancy test
- Women who did not consent to contraception in a medically acceptable way during the trial
- Medically acceptable contraceptive methods: use condoms, injectable or injectable contraceptives, intrauterine contraceptive device, etc.
- If the tester judges that the participation in the clinical trial is not legal or mental character
- Clinical studies with other clinical trial drugs within 4 weeks prior to screening patients with experience
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites, 10 recruiting
- Recruiting
Hallym University Medical Center
Anyang, Dongan-gu, 14068
Sang-Ho Jo, 82-31-380-3722, sophi5neo@gmail.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 463707
Dong-Ju Choi, MD, PhD, 82-31-787-7007, djchoi@snubh.org
Jin Joo Park, MD, 82-31-787 ext. 7074, jinjooparkmd@gmail.com
- Recruiting
Kyung Hee University Hospital
Seoul, Dongdaemun-gu, 02447
Soo-Joong Kim, 82-2-958-8180, soojoong@dreamwiz.com
- Recruiting
Hallym University Medical Center
Seoul, Gangdong-gu,, 05355
Kyoo-Rok Han, 82-2-2224-2405, krheart@hallym.or.kr
- Recruiting
Samsung Medical Center
Seoul, Gangnam-Gu, 06351
Sung-Ji Park, 82-2-3410-0887, tyche.park@gmail.com
- Recruiting
Korea Univ. Guro Hospital
Seoul, Guro, 08308
Eung-ju Kim, MD,PhD, 82-8-2626-3022, withnoel@empas.com
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Hyun-Jai Cho, 82-2-2072-3931, hyunjaicho@snu.ac.kr
- Recruiting
Hanyang University Medical Center
Seoul, Seongdong-gu, 04763
Jin-Ho Shin, 82-2-2290-8308, jhs2003@hanyang.ac.kr
- Recruiting
Asan Medical Center
Seoul, Songpa-gu, 05505
Jong-Min Song, 82-2-3010-3158, jmsong@amc.seoul.kr
- Recruiting
Ajou Univ. Medical Center
Suwon, Yeong-tong, 16499
Joon-han Shin, MD,PhD, 82-31-219-5710, shinjh@ajou.ac.kr
About this study
Official title: Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With Calcium Channel Blocker Monotherapy
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With CCB(Calcium Channel Blocker) Monotherapy
Read the detailed description
The aim of this study is to verify the difference at week 12 from the baseline value in the average variation of diastolic blood pressure (sitDBP) of the study group in which S-amlodipine / Chlorthalidone combination therapy is to be used in patients with essential hypertension who did not adequately respond to monotherapy of amlodipine or S-amlodipine, compared to the control group, in which a combination therapy of S-amlodipine / telmisartan is to be used.
- Conditions
- Essential Hypertension
- Being tested
- S-amlodipine 2.5mg + Chlorthalidone 25mg, S-amlodipine 2.5mg + Telmisartan 40mg
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-amlodipine 2.5mg + Chlorthalidone 25mgDrug
patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
S-amlodipine 2.5mg + Telmisartan 40mgDrug
patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| S-amlodipine + Chlorthalidone | Experimental | patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks. Receives: Drug: S-amlodipine 2.5mg + Chlorthalidone 25mg |
| S-amlodipine + Telmisartan | Active comparator | patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks. Receives: Drug: S-amlodipine 2.5mg + Telmisartan 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
sit diastolic blood pressure
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.
Measured: 12 weeks
Secondary outcomes (3)
sit diastolic blood pressure
Mean change in sit diastolic blood pressure after 6 weeks compared to baseline.
Measured: 6 weeks
sit systolic blood pressure
Mean change in sit systolic blood pressure after 6 weeks and 12 weeks compared to baseline.
Measured: 12 weeks
Blood pressure normalization
Blood pressure normalization ratio after 12 weeks compared to baseline( sit systolic blood pressure <140 mmHg or sit diastolic blood pressure <90 mmHg).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start2 Dec 2015
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
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.
- More trials run by Seoul National University Bundang HospitalThe 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
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226340
- Sponsor's protocol ID
- HL_LDN_504
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jo SH, Park SJ, Kim EJ, Kim SJ, Cho HJ, Song JM, Shin J, Park JJ, Shin JH, Han KR, Choi DJ. S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial. Trials. 2018 Jun 20;19(1):324. doi: 10.1186/s13063-018-2636-1.
PubMed 29925421
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With Calcium Channel Blocker Monotherapy
- ClinicalTrials.gov ID
- NCT03226340
- Acronym / sponsor ID
- HL_LDN_504
- Conditions
- Essential Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Hanlim Pharm. Co., Ltd.
- Study start
- 2 Dec 2015 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 21 Jul 2017 (actual)
- 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.
Evaluation of the Efficacy and Safety of S-amlodipine+Chlorthalidone Combination Therapy and S-amlodipine+Telmisartan Combination Therapy in Hypertensive Patients Inadequately Controlled With CCB(Calcium Channel Blocker) Monotherapy
Detailed description
The aim of this study is to verify the difference at week 12 from the baseline value in the average variation of diastolic blood pressure (sitDBP) of the study group in which S-amlodipine / Chlorthalidone combination therapy is to be used in patients with essential hypertension who did not adequately respond to monotherapy of amlodipine or S-amlodipine, compared to the control group, in which a combination therapy of S-amlodipine / telmisartan is to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-amlodipine + Chlorthalidone | Experimental | Drug: S-amlodipine 2.5mg + Chlorthalidone 25mgpatients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks. |
| S-amlodipine + Telmisartan | Active comparator | Drug: S-amlodipine 2.5mg + Telmisartan 40mgpatients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women with essential hypertension who were aged 19 years or older and younger than 80 years
- Patients who have been treated with amlodipine or S-amlodipine monotherapy for more than 2 weeks immediately before visit 1 (screening)
- Visit 1 (screening) reference mean blood pressure measured three times in the arm is greater than sit DBP 90 mmHg
- Those who have voluntarily agreed in writing to participate in the trial
Key exclusion criteria (26 listed)
- Patients with a history of secondary hypertension and all those with suspected secondary hypertension (including, but not limited to, coarctation of the aorta, primary aldosteronism, renal artery stenosis, Cushing's syndrome, chromium-rich cell tumor, polycystic kidney disease, etc.)
- Patients with a mean SBP of 200 mmHg or more or a sit DBP of 110 mmHg or more at visit 1.
- When the blood pressure was measured three times in the reference arm of visit 1 (screening), the difference between the highest lowest sit SBP was 20 mmHg or higher and the difference between the highest lowest sit DBP was 10 mmHg or higher.
- An uncontrolled diabetic patient(HbA1c≥9.0%)
- In addition to antihypertensive drugs, drugs that may affect blood pressure( Systemic steroids, Thyroid hormones, Oral contraceptives, antipsychotic drugs, NSAIDs, sympathomimetics, immunosuppressants, etc.) have been continuously administered for more than 12 weeks prior to visit 1 (screening)
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 |
|---|---|---|
| S-amlodipine 2.5mg + Chlorthalidone 25mgpatients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks. | Drug | S-amlodipine + Chlorthalidone |
| S-amlodipine 2.5mg + Telmisartan 40mgpatients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks. | Drug | S-amlodipine + Telmisartan |
Primary outcome
sit diastolic blood pressure
Time frame: 12 weeks
Mean change in sit diastolic blood pressure after 12 weeks compared to baseline.
3 secondary outcomes
sit diastolic blood pressure
Time frame: 6 weeks
sit systolic blood pressure
Time frame: 12 weeks
Blood pressure normalization
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Derived from this study: PubMed 29925421Jo SH, Park SJ, Kim EJ, Kim SJ, Cho HJ, Song JM, Shin J, Park JJ, Shin JH, Han KR, Choi DJ. S-amlodipine plus chlorthalidone vs. S-amlodipine plus telmisartan in hypertensive patients unresponsive to amlodipine monotherapy: study protocol for a randomized controlled trial. Trials. 2018 Jun 20;19(1):324. doi: 10.1186/s13063-018-2636-1.
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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.
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 S-amlodipine 2.5mg + Chlorthalidone 25mg and S-amlodipine 2.5mg + Telmisartan 40mg in people with Essential Hypertension, run by Seoul National University Bundang Hospital 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 4 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 21 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sit diastolic blood pressure (time frame: 12 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 NCT03226340, 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 21 Jul 2017.