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A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome (PRISTINE)

Primary Purpose

Essential Hypertension, Metabolic Syndrome

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Telmisartan
Losartan
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: [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 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) Exclusion Criteria: 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%)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Telmisartan

    Losartan

    Arm Description

    Telmitrend Tab.(Telmisartan) 40mg(80mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg

    Cozaar Tab.(Losartan) 50mg(100mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg

    Outcomes

    Primary Outcome Measures

    MSSBP change
    MSSBP change between administration groups after 12 weeks (Visit 4) compared to baseline (Visit 2)

    Secondary Outcome Measures

    MSSBP change
    MSSBP change between administration groups after 6 weeks (Visit 3) compared to baseline (Visit 2)
    MSDBP change
    MSDBP change between administration groups compared to baseline (Visit 2) after 6 weeks (Visit 3) and 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
    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
    Changes in HOMA-IR
    Changes in HOMA-IR[(Fasting insulin(mU/L)×Fasting glucose(nmol/L))/22.5]
    Changes in HOMA-β
    Changes in HOMA-β[(20×Fasting insulin(mU/L))/(Fasting glucose(nmol/L)-3.5)]
    Changes in Glucose
    Changes in Glucose(nmol/L)
    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
    Changes in HbA1c
    Changes in HbA1c (%) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups

    Full Information

    First Posted
    March 9, 2023
    Last Updated
    May 3, 2023
    Sponsor
    Chong Kun Dang Pharmaceutical
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05843162
    Brief Title
    A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
    Acronym
    PRISTINE
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chong Kun Dang Pharmaceutical

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Essential Hypertension, Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    116 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Telmisartan
    Arm Type
    Experimental
    Arm Description
    Telmitrend Tab.(Telmisartan) 40mg(80mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg
    Arm Title
    Losartan
    Arm Type
    Active Comparator
    Arm Description
    Cozaar Tab.(Losartan) 50mg(100mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg
    Intervention Type
    Drug
    Intervention Name(s)
    Telmisartan
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Losartan
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    MSSBP change
    Description
    MSSBP change between administration groups after 12 weeks (Visit 4) compared to baseline (Visit 2)
    Time Frame
    Baseline (Visit 2), 12 weeks (Visit 4)
    Secondary Outcome Measure Information:
    Title
    MSSBP change
    Description
    MSSBP change between administration groups after 6 weeks (Visit 3) compared to baseline (Visit 2)
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3)
    Title
    MSDBP change
    Description
    MSDBP change between administration groups compared to baseline (Visit 2) after 6 weeks (Visit 3) and 12 weeks (Visit 4)
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Blood pressure normalization ratio
    Description
    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
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Blood pressure response rate
    Description
    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
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Changes in HOMA-IR
    Description
    Changes in HOMA-IR[(Fasting insulin(mU/L)×Fasting glucose(nmol/L))/22.5]
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Changes in HOMA-β
    Description
    Changes in HOMA-β[(20×Fasting insulin(mU/L))/(Fasting glucose(nmol/L)-3.5)]
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Changes in Glucose
    Description
    Changes in Glucose(nmol/L)
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Changes in Insulin
    Description
    Changes in Insulin(mU/L) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
    Title
    Changes in HbA1c
    Description
    Changes in HbA1c (%) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups
    Time Frame
    Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: [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 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) Exclusion Criteria: 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%)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Soo Lee, MD
    Phone
    82-31-787-7035
    Email
    limsoo@snu.ac.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Soo MD, MD
    Organizational Affiliation
    Seoul National University Bundang Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome

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