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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
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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
Start Date
June 1, 2023
Primary Completion Date
December 31, 2023
Completion Date
December 31, 2023
Last Updated
May 6, 2023
116
ESTIMATED participants
Telmisartan
DRUG
Losartan
DRUG
Lead Sponsor
Chong Kun Dang Pharmaceutical
NCT07237750
NCT07460856
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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