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

Metabolic Syndrome Clinical Trial

— PRISTINE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05843162
• Other study ID #: B115_01HT/MS2201
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: Soo Lee, MD
• Phone: 82-31-787-7035
• Email: limsoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 ?~? satisfy ? fasting blood glucose standards, and those who meet at least one of ?~? criteria (? Fasting blood sugar: =100 mg/dL or a state in which medication is being administered to control blood sugar, ? Waist circumference: male =90 cm, female =85 cm, ? HDL-cholesterol: male <40 mg/dL, female <50 mg/dL or taking medication to increase HDL-cholesterol, ? 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 ? to ? satisfy ? fasting blood sugar criteria, and those who meet at least one of ? to ? criteria (? Fasting blood sugar: =100 mg/dL or a state in which medication is being administered to control blood sugar, ? Waist circumference: male =90 cm, female =85 cm, ? HDL-cholesterol: male <40 mg/dL, female <50 mg/dL or taking medication to increase HDL-cholesterol, ? 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%)

Related Conditions & MeSH terms

• Essential Hypertension
• Metabolic Syndrome
• Syndrome

Intervention

Drug:
• Telmisartan
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.
• Losartan
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MSSBP change	MSSBP change between administration groups after 6 weeks (Visit 3) compared to baseline (Visit 2)	Baseline (Visit 2), 6 weeks (Visit 3)
Secondary	MSDBP change	MSDBP change between administration groups compared to baseline (Visit 2) after 6 weeks (Visit 3) and 12 weeks (Visit 4)	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	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	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	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	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	Changes in HOMA-IR	Changes in HOMA-IR[(Fasting insulin(mU/L)×Fasting glucose(nmol/L))/22.5]	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	Changes in HOMA-ß	Changes in HOMA-ß[(20×Fasting insulin(mU/L))/(Fasting glucose(nmol/L)-3.5)]	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	Changes in Glucose	Changes in Glucose(nmol/L)	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	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	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)
Secondary	Changes in HbA1c	Changes in HbA1c (%) after 6 weeks (Visit 3) and 12 weeks (Visit 4) compared to baseline (Visit 2) between administration groups	Baseline (Visit 2), 6 weeks (Visit 3), 12 weeks (Visit 4)