Ignite Creation Date:
2024-05-05 @ 7:13 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00624052
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2008-02-05
Brief Title:
26-week Open Study of telmisartan40mgamlodipine10mg or telmisartan80mgamlodipine10 mg in Hypertension
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Open Label Trial of the Efficacy and Safety of Chronic Administration of the Fixed Dose Combination of Telmisartan 40mg Amlodipine 10mg or Fixed Dose Combination of Telmisartan 80mg Amlodipine 10mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension
Status:
COMPLETED
Status Verified Date:
2014-05
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:
None
Brief Summary:
The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40mgamlodipine 10mg T40A10 or telmisartan 80mgamlodipine 10mg T80A10 during open-label treatment for at least six months
An additional objective is to assess the efficacy and safety of concomitant administration of either T40A10 or T80A10 with any other therapies commonly used in the treatment of hypertension
The primary endpoint is the proportion of patients achieving DBP control defined as mean seated DBP 90 mmHg at trough ie approximately 24 hours after last dose of study treatment at six months of treatment or at last trough observation during the treatment period ie last trough observation carried forward
An additional objective is to assess the efficacy and safety of concomitant administration of either T40A10 or T80A10 with any other therapies commonly used in the treatment of hypertension
The primary endpoint is the proportion of patients achieving DBP control defined as mean seated DBP 90 mmHg at trough ie approximately 24 hours after last dose of study treatment at six months of treatment or at last trough observation during the treatment period ie last trough observation carried forward
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