Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386529
Status:
COMPLETED
Last Update Posted:
2010-12-15
First Post:
2006-10-09
Brief Title:
Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-controlled Hypertensive Patients
Sponsor:
Boryung Pharmaceutical Co Ltd
Organization:
Boryung Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multi-center Double-Blind Randomized Cross-over Active-control Comparative Clinical Study to Evaluate the Administration Time-dependent Antihypertensive Effects of Low Dose Aspirin in Well-Controlled Hypertensive Patients Phase IV
Status:
COMPLETED
Status Verified Date:
2010-12
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:
None
Brief Summary:
The purpose of this study is to evaluate the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day
Detailed Description:
Recent studies showed that low dose aspirin exerts a significant administration time-dependent effect on blood pressure in previously untreated hypertensive patients However this effect has not been confirmed in patients taking low-dose aspirin in combination with antihypertensive medications A multi-center double-blind randomized cross-over active-control comparative clinical study will be conducted to evaluate the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day
Approximately 192 patients will be enrolled over 4 months in 8 centers nationwide
After placebo run-in period all subjects will be randomized into one of the following 3 groups
Group I II will take low dose aspirin for treatment period for first and second 12 weekson awakening or before bed time Group III will take placebo for treatment period
After first 12 weeks treatment period the subjects will be informed whether shehe belongs to Group III This will be done without breaking the double blinding in the other 2 groups
The primary objective will be the evaluation of the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day
The secondary objectives will be 1 comparison of the administration time-dependent effects of low dose aspirin on blood pressure between dipper and non-dipper patients and 2 the evaluation of the effects of low dose aspirin in Korean hypertensive patients
A sub-study will be conducted in 3 centers to evaluate the effect of aspirin on endothelial function in patients with well-controlled hypertension
Approximately 192 patients will be enrolled over 4 months in 8 centers nationwide
After placebo run-in period all subjects will be randomized into one of the following 3 groups
Group I II will take low dose aspirin for treatment period for first and second 12 weekson awakening or before bed time Group III will take placebo for treatment period
After first 12 weeks treatment period the subjects will be informed whether shehe belongs to Group III This will be done without breaking the double blinding in the other 2 groups
The primary objective will be the evaluation of the influence of aspirin on blood pressure in well-controlled hypertensive patients who receive low dose aspirin at different times of the day
The secondary objectives will be 1 comparison of the administration time-dependent effects of low dose aspirin on blood pressure between dipper and non-dipper patients and 2 the evaluation of the effects of low dose aspirin in Korean hypertensive patients
A sub-study will be conducted in 3 centers to evaluate the effect of aspirin on endothelial function in patients with well-controlled hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None