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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
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.
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.
MSSBP change
MSSBP change between administration groups after 12 weeks (Visit 4) compared to baseline (Visit 2)
Time frame: Baseline (Visit 2), 12 weeks (Visit 4)
MSSBP change
MSSBP change between administration groups after 6 weeks (Visit 3) compared to baseline (Visit 2)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HOMA-IR
Changes in HOMA-IR\[(Fasting insulin(mU/L)×Fasting glucose(nmol/L))/22.5\]
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in HOMA-β
Changes in HOMA-β\[(20×Fasting insulin(mU/L))/(Fasting glucose(nmol/L)-3.5)\]
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Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Changes in Glucose
Changes in Glucose(nmol/L)
Time frame: 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
Time frame: 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
Time frame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)