Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326768
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-05-16
Brief Title:
Trial of Telmisartan 80 mgHCTZ 125 mg and Telmisartan 40 mgHCTZ 125 mg in Patients With Hypertension
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open-Label Long-term 52-week Safety Trial of the Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 125mg and Telmisartan 40mg Plus Hydrochlorothiazide 125mg in Patients With Essential Hypertension - Efficacy and Safety Evaluation
Status:
COMPLETED
Status Verified Date:
2017-12
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 objective of this trial is to assess the safety and efficacy of 52 weeks of open-label treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 125 mg and telmisartan 40 mg plus HCTZ 125 mg in patients with essential hypertension
Detailed Description:
This is a multi-centre study with three centres participating with a target of 30 to 90 patients entering the maintenance period and 20-60 patients completing long-term treatment per centre The recruitment period will be about three months from the start of the study
Study Hypothesis
The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartanHCTZ fixed-dose combination treatment This study has no control group therefore no hypothesis testing will be performed
Comparisons
This study has no control group
Study Hypothesis
The primary objective of this study is to demonstrate the long-term safety of a fixed dose combination of telmisartanHCTZ fixed-dose combination treatment This study has no control group therefore no hypothesis testing will be performed
Comparisons
This study has no control group
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