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

Chong Kun Dang

Status and phase: Not yet enrolling; Phase 4

Conditions: Essential Hypertension; Metabolic Syndrome

Treatments: Drug: Telmisartan; Drug: Losartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT05843162

B115_01HT/MS2201

Details and patient eligibility

About

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

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Telmisartan

Experimental group

Description:

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

Treatment:

Drug: Telmisartan

Losartan

Active Comparator group

Description:

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

Treatment:

Drug: Losartan