Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257491
Status:
COMPLETED
Last Update Posted:
2013-11-11
First Post:
2005-11-22
Brief Title:
Study to Evaluate the Trough and Peak Effect of Once Daily Telmisartan 80 mgHydrochlorothiazide 125 mg Micardis Plus by Ambulatory Blood Pressure Monitoring ABPM in Patients With Mild to Moderate Essential Hypertension
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-label Study to Evaluate the Trough and Peak Effect of Once Daily Micardis Plus Telmisartan 80mg Hydrochlorothiazide 125 mg by 24 ABPM in Patients With Mild to Moderate Essential Hypertension
Status:
COMPLETED
Status Verified Date:
2013-11
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:
To evaluate the trough and peak effect of once daily MICARDIS PLUS Telmisartan 80 mghydrochlorothiazide 125 mg by 24 ABPM in patients with mild to moderate essential hypertension
Detailed Description:
This study is designed as an open label study After a 2-week placebo run-in phase qualified patients will be administered with telmisartan 80mg for 2 weeks then forcefully titrated to telmisartan 80 mg and hydrochlorothiazide 125 mg fixed dose combination for 6 weeks 24 hour ABPM will be performed at the end of placebo run-in period baseline and after 8 weeks of active treatment
Study Hypothesis
The primary analyses will be the calculation of trough to peak ratios TP ratios for DBP and SBP The TP ratio will be calculated on the basis of changes in hourly means related to dosing time from baseline DeltaHM Trough is defined as the mean of the last three hours of the 24-hour dosing interval Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing Thus TP is calculated as TP meanDeltaHM22 - DeltaHM24min DeltaHM2 - DeltaHM8
Comparisons
To assess troughpeak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential hypertension
Study Hypothesis
The primary analyses will be the calculation of trough to peak ratios TP ratios for DBP and SBP The TP ratio will be calculated on the basis of changes in hourly means related to dosing time from baseline DeltaHM Trough is defined as the mean of the last three hours of the 24-hour dosing interval Peak is the greatest reduction in hourly means in hours 2 to 8 after dosing Thus TP is calculated as TP meanDeltaHM22 - DeltaHM24min DeltaHM2 - DeltaHM8
Comparisons
To assess troughpeak ratio of once daily Micardis plus by 24 ABPM in patients with mild to moderate essential 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