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

NCT05843162 | Unknown Phase 4

• 1 other identifier: B115_01HT/MS2201
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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

Conditions

Essential Hypertension; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• MSSBP change

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

  Baseline (Visit 2), 12 weeks (Visit 4)

Secondary Outcomes (9)

• MSSBP change

  Baseline (Visit 2), 6 weeks (Visit 3)

• MSDBP change

  Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)

• Blood pressure normalization ratio

  Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)

• Blood pressure response rate

  Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)

• Changes in HOMA-IR

  Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)

Study Arms (2)

Telmisartan

EXPERIMENTAL

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

Drug: Telmisartan

Losartan

ACTIVE COMPARATOR

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

Drug: Losartan

Interventions

Telmisartan DRUG

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.

Telmisartan

Losartan DRUG

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.

Losartan

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Screening/Run-in period (Visit 1)\]
• 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
• mmHg ≤ mean sitting systolic blood pressure (MSSBP) \< 180 mmHg
• 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)

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

MeSH Terms

Conditions

Essential Hypertension; Metabolic Syndrome

Interventions

Telmisartan; Losartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles

Study Officials

• Soo MD, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Lee, MD

CONTACT

82-31-787-7035; limsoo@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share