A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
- Conditions
- Essential HypertensionMetabolic Syndrome
- Interventions
- Registration Number
- NCT05843162
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 116
[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)
-
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%)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan Telmisartan Telmitrend Tab.(Telmisartan) 40mg(80mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg Losartan Losartan Cozaar Tab.(Losartan) 50mg(100mg) + Anydipine-S(S-amlodipine) Tab. 2.5mg
- Primary Outcome Measures
Name Time Method MSSBP change Baseline (Visit 2), 12 weeks (Visit 4) MSSBP change between administration groups after 12 weeks (Visit 4) compared to baseline (Visit 2)
- Secondary Outcome Measures
Name Time Method MSDBP change Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) MSDBP change between administration groups compared to baseline (Visit 2) after 6 weeks (Visit 3) and 12 weeks (Visit 4)
Blood pressure normalization ratio Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) 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 Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) 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
MSSBP change Baseline (Visit 2), 6 weeks (Visit 3) MSSBP change between administration groups after 6 weeks (Visit 3) compared to baseline (Visit 2)
Changes in Glucose Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) Changes in Glucose(nmol/L)
Changes in HbA1c Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) Changes in HbA1c (%) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups
Changes in HOMA-IR Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) Changes in HOMA-IR\[(Fasting insulin(mU/L)×Fasting glucose(nmol/L))/22.5\]
Changes in HOMA-β Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) Changes in HOMA-β\[(20×Fasting insulin(mU/L))/(Fasting glucose(nmol/L)-3.5)\]
Changes in Insulin Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4) Changes in Insulin(mU/L) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups