Clinical trial NCT05843162: A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Essential Hypertension
Metabolic Syndrome
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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%)

Primary outcomes:
measure: MSSBP change
timeFrame: Baseline (Visit 2), 12 weeks (Visit 4)
Secondary outcomes:
measure: MSSBP change
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3)
measure: MSDBP change
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Blood pressure normalization ratio
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Blood pressure response rate
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Changes in HOMA-IR
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Changes in HOMA-β
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Changes in Glucose
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Changes in Insulin
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
measure: Changes in HbA1c
timeFrame: Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo MD, MD
role: PRINCIPAL_INVESTIGATOR
References: