Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05843162
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-06
First Post:
2023-03-09
Brief Title:
A Clinical Trial to Evaluate the Blood Pressure Control of Telmisartan or Losartan in Essential Hypertensive Patients With Metabolic Syndrome
Sponsor:
Chong Kun Dang Pharmaceutical
Organization:
Chong Kun Dang Pharmaceutical
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISTINE
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 11 ratio to the following group the test group Telmisartan 40 mg S-Amlodopine 25 mg the control group Losartan 50 mg S-Amlodopine 25 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 4End of study However if the need of dose increasing is not required according to the investigators 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 timeam for 12 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None