Essential HypertensionPhase 4PRISTINENCT05843162
A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
A Phase 4 study testing Telmisartan and Losartan in people with Essential Hypertension and Metabolic Syndrome, run by Chong Kun Dang Pharmaceutical.
Trial summary
This is a multi-center, randomized, open-label, active comparator-controlled, phase 4 clinical trial to evaluate the blood pressure control of Telmisartan or Losartan in essential hypertensive patients with metabolic syndrome Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Essential Hypertension, Metabolic Syndrome
- What is being tested?
- Telmisartan and Losartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 Dec 2023
- 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
- [Screening/Run-in period (Visit 1)]
- Adults over 19 years of age
- Patients who have been diagnosed with essential hypertension or who are taking antihypertensive drugs after diagnosis (However, if you are already taking antihypertensive drugs, you can discontinue/change the antihypertensive drugs and agree to this)
- At the time of screening/introduction (Visit 1), the following metabolic syndrome diagnosis criteria ①~④ satisfy ① fasting blood glucose standards, and those who meet at least one of ②~④ criteria (① Fasting blood sugar: ≥100 mg/dL or a state in which medication is being administered to control blood sugar, ② Waist circumference: male ≥90 cm, female ≥85 cm, ③ HDL-cholesterol: male <40 mg/dL, female <50 mg/dL or taking medication to increase HDL-cholesterol, ④ Triglyceride: ≥150 mg/dL or taking medication to lower triglyceride)
- [Randomization (Visit 2)]
- Patients whose average sitting systolic or diastolic blood pressure measured in the arm selected as the reference arm during the screening test at the time of randomization (Visit 2) corresponds to the following
Show all 9Show fewer
- 140 mmHg ≤ mean sitting systolic blood pressure (MSSBP) < 180 mmHg
- 90 mmHg ≤ mean sitting diastolic blood pressure (MSDBP) < 110 mmHg
- At the time of randomization (Visit 2), the following metabolic syndrome diagnosis criteria ① to ④ satisfy ① fasting blood sugar criteria, and those who meet at least one of ② to ④ criteria (① Fasting blood sugar: ≥100 mg/dL or a state in which medication is being administered to control blood sugar, ② Waist circumference: male ≥90 cm, female ≥85 cm, ③ HDL-cholesterol: male <40 mg/dL, female <50 mg/dL or taking medication to increase HDL-cholesterol, ④ Triglyceride: ≥150 mg/dL or taking medication to lower triglyceride)
Who cannot join
- Patients whose blood pressure measured at the time of screening/introduction (Visit 1) corresponds to any of the following
- Patients with MSSBP ≥180 mmHg or MSDBP ≥110 mmHg
- Patients with MSSBP ≥20 mmHg and MSDBP ≥10 mmHg difference in blood pressure measured 3 times in each arm
- Patients with a history of secondary hypertension or suspected secondary hypertension (aortic coarctation, hyperaldosteronemia, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
- Patients with orthostatic hypotension with symptoms
- Patients with type 1 diabetes or poorly controlled diabetes (HbA1c >9.0%)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
This is a multi-center, randomized, open-label, active comparator-controlled, phase 4 clinical trial to evaluate the blood pressure control of Telmisartan or Losartan in essential hypertensive patients with metabolic syndrome
Read the detailed description
Participants were randomly assigned in a 1:1 ratio to the following group; the test group [Telmisartan 40 mg + S-Amlodopine 2.5 mg], the control group [Losartan 50 mg + S-Amlodopine 2.5 mg]. If the blood pressure measured at 6 weeks time (Visit 3) based on the random allocation date (Visit 2) is MSSBP ≥140 mmHg or MSDBP ≥90 mmHg, the test group will increase the Telmisartan 80 mg, the control group will increase the dose to 100 mg for 6 weeks from Visit 3 to Visit 4(End of study). However, if the need of dose increasing is not required according to the investigator's judgment, the current dose can be maintained. All clinical trial drugs are administered orally once a day, and it is recommended to be administered at the same time(am) for 12 weeks.
- Conditions
- Essential Hypertension, Metabolic Syndrome
- Being tested
- Telmisartan, Losartan
- Medical subject headings
- Essential Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
Subjects assigned to the test group are oral administered Telmisartan 40 mg and S-Amlodopine 2.5 mg once a day for 12 weeks. However, if the blood pressure measured at 6 weeks after random allocation (Visit 3) is MSSBP ≥140 mmHg or MSDBP ≥ 90 mmHg, increase the dose to Telmisartan 80 mg for 6 weeks from Visit 3 to Visit 4 (End of study). However, if the need of dose increasing is not required according to the tester's judgment, the current dose can be maintained.
LosartanDrug
Subjects assigned to the control group are oral administered Losartan 50 mg and S-Amlodopine 2.5 mg once a day for 12 weeks. However, if the blood pressure measured at 6 weeks after random allocation (Visit 3) is MSSBP ≥140 mmHg or MSDBP ≥ 90 mmHg, increase the dose to Losartan 100 mg for 6 weeks from Visit 3 to Visit 4 (End of study). However, if the need of dose increasing is not required according to the tester's judgment, the current dose can be maintained.
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Telmitrend Tab.(Telmisartan) 40mg(80mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg Receives: Drug: Telmisartan |
| Losartan | Active comparator | Cozaar Tab.(Losartan) 50mg(100mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg Receives: Drug: Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSSBP change
MSSBP change between administration groups after 12 weeks (Visit 4) compared to baseline (Visit 2)
Measured: Baseline (Visit 2), 12 weeks (Visit 4)
Secondary outcomes (9)
MSSBP change
MSSBP change between administration groups after 6 weeks (Visit 3) compared to baseline (Visit 2)
Measured: Baseline (Visit 2), 6 weeks (Visit 3)
MSDBP change
MSDBP change between administration groups compared to baseline (Visit 2) after 6 weeks (Visit 3) and 12 weeks (Visit 4)
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Blood pressure normalization ratio
Blood pressure normalization ratio (ratio of subjects with MSSBP <140 mmHg and MSDBP <90 mmHg) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Blood pressure response rate
Blood pressure response rate (MSSBP reduction ≥20 mmHg and MSDBP reduction ≥10 mmHg) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between treatment groups
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HOMA-IR
Changes in HOMA-IR[(Fasting insulin(mU/L)×Fasting glucose(nmol/L))/22.5]
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HOMA-β
Changes in HOMA-β[(20×Fasting insulin(mU/L))/(Fasting glucose(nmol/L)-3.5)]
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in Glucose
Changes in Glucose(nmol/L)
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in Insulin
Changes in Insulin(mU/L) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HbA1c
Changes in HbA1c (%) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups
Measured: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soo MD, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843162
- Sponsor's protocol ID
- B115_01HT/MS2201
- Acronym
- PRISTINE
- Status last verified
- May 2023
- First submitted
- 9 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Open-label, Active Comparator-controlled, Phase 4 Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05843162
- Acronym / sponsor ID
- PRISTINE / B115_01HT/MS2201
- Conditions
- Essential Hypertension, Metabolic Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 May 2023 (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.
This is a multi-center, randomized, open-label, active comparator-controlled, phase 4 clinical trial to evaluate the blood pressure control of Telmisartan or Losartan in essential hypertensive patients with metabolic syndrome
Detailed description
Participants were randomly assigned in a 1:1 ratio to the following group; the test group [Telmisartan 40 mg + S-Amlodopine 2.5 mg], the control group [Losartan 50 mg + S-Amlodopine 2.5 mg]. If the blood pressure measured at 6 weeks time (Visit 3) based on the random allocation date (Visit 2) is MSSBP ≥140 mmHg or MSDBP ≥90 mmHg, the test group will increase the Telmisartan 80 mg, the control group will increase the dose to 100 mg for 6 weeks from Visit 3 to Visit 4(End of study). However, if the need of dose increasing is not required according to the investigator's judgment, the current dose can be maintained. All clinical trial drugs are administered orally once a day, and it is recommended to be administered at the same time(am) for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: TelmisartanTelmitrend Tab.(Telmisartan) 40mg(80mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg |
| Losartan | Active comparator | Drug: LosartanCozaar Tab.(Losartan) 50mg(100mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- [Screening/Run-in period (Visit 1)]
- Adults over 19 years of age
- Patients who have been diagnosed with essential hypertension or who are taking antihypertensive drugs after diagnosis (However, if you are already taking antihypertensive drugs, you can discontinue/change the antihypertensive drugs and agree to this)
- At the time of screening/introduction (Visit 1), the following metabolic syndrome diagnosis criteria ①~④ satisfy ① fasting blood glucose standards, and those who meet at least one of ②~④ criteria (① Fasting blood sugar: ≥100 mg/dL or a state in which medication is being administered to control blood sugar, ② Waist circumference: male ≥90 cm, female ≥85 cm, ③ HDL-cholesterol: male <40 mg/dL, female <50 mg/dL or taking medication to increase HDL-cholesterol, ④ Triglyceride: ≥150 mg/dL or taking medication to lower triglyceride)
- [Randomization (Visit 2)]
Key exclusion criteria (6 listed)
- Patients whose blood pressure measured at the time of screening/introduction (Visit 1) corresponds to any of the following
- Patients with a history of secondary hypertension or suspected secondary hypertension (aortic coarctation, hyperaldosteronemia, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
- Patients with orthostatic hypotension with symptoms
- Patients with type 1 diabetes or poorly controlled diabetes (HbA1c >9.0%)
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 |
|---|---|---|
| TelmisartanSubjects assigned to the test group are oral administered Telmisartan 40 mg and S-Amlodopine 2.5 mg once a day for 12 weeks. However, if the blood pressure measured at 6 weeks after random allocation (Visit 3) is MSSBP ≥140 mmHg or MSDBP ≥ 90 mmHg, increase the dose to Telmisartan 80 mg for 6 weeks from Visit 3 to Visit 4 (End of study). However, if the need of dose increasing is not required according to the tester's judgment, the current dose can be maintained. | Drug | Telmisartan |
| LosartanSubjects assigned to the control group are oral administered Losartan 50 mg and S-Amlodopine 2.5 mg once a day for 12 weeks. However, if the blood pressure measured at 6 weeks after random allocation (Visit 3) is MSSBP ≥140 mmHg or MSDBP ≥ 90 mmHg, increase the dose to Losartan 100 mg for 6 weeks from Visit 3 to Visit 4 (End of study). However, if the need of dose increasing is not required according to the tester's judgment, the current dose can be maintained. | Drug | Losartan |
Primary outcome
MSSBP change
Time frame: Baseline (Visit 2), 12 weeks (Visit 4)
MSSBP change between administration groups after 12 weeks (Visit 4) compared to baseline (Visit 2)
9 secondary outcomes
MSSBP change
Time frame: Baseline (Visit 2), 6 weeks (Visit 3)
MSDBP change
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Blood pressure normalization ratio
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Blood pressure response rate
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HOMA-IR
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HOMA-β
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in Glucose
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in Insulin
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HbA1c
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- 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.
Soo MD, MD principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan and Losartan in people with Essential Hypertension and Metabolic Syndrome, run by Chong Kun Dang Pharmaceutical.
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 9 inclusion and 6 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Soo Lee, MD (82-31-787-7035, limsoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSSBP change (time frame: Baseline (Visit 2), 12 weeks (Visit 4)). 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 6 May 2023.