Ignite Creation Date:
2024-05-06 @ 2:58 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02172586
Status:
COMPLETED
Last Update Posted:
2014-06-24
First Post:
2014-06-20
Brief Title:
Telmisartan With or Without Hydrochlorothiazide HCTZ Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A PROBE Prospective Randomised Open-label Blinded Endpoint Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks and of Telmisartan 80 mg HCTZ 125 mg Once Daily Compared With Losartan 100 mg Once Daily HCTZ 125 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients Grade 1 and Grade 2 WHO-ISH Guidelines 1999
Status:
COMPLETED
Status Verified Date:
2014-06
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:
Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure DBP during the last 6 hours of the 24-hour dosing interval at the end of the 12 weeks period of monotherapy treatment ABPM - ambulatory blood pressure measurement
Secondary objectives Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study evaluated by sphygmomanometric blood pressure measurement and ABPM
Safety
Incidence of adverse events AEs withdrawal due to adverse events laboratory parameters
Secondary objectives Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study evaluated by sphygmomanometric blood pressure measurement and ABPM
Safety
Incidence of adverse events AEs withdrawal due to adverse events laboratory parameters
Detailed Description:
None
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