Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01286558
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2011-01-28
Brief Title:
Comparison in Japan T80A5 Telmisartan 80 mg and Amlodipine 5 mg and T40A5 Telmisartan 40 mg and Amlodipine 5 mg
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg Plus Amlodipine 5 mg Fixed-dose Combination vs Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination in Patients With Hypertension
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Blood pressure in hypertensive patients is rarely controlled to an optimal level by one drug alone often a combination of two or more drugs is essential to achieve a sufficient antihypertensive effect Therefore in Japanese Society of Hypertension JSH 2009 combination therapy is recommended In JSH 2009 it is advised to start the combination therapy at a low dose and to increase the dosage when the antihypertensive effect is not sufficient In the Japanese long-term safety study 259 patients received the T40A5 mg fixed-dose combination FDC and after 6 weeks treatment 48 patients of them could not control their blood pressure DBP 90 U09-2494-01 For those patients who cannot control their blood pressure with T40A5 mg FDC a switch to a higher dose such as T80A5 mg is recommended
In the overseas 4x4 factorial design trial a clinically meaningful difference of the blood pressure lowering effect between T80A5 mg free combination and T40A5 mg free combination was shown U07-3503-02 But the sponsor has no data that verifies this difference in Japanese patients
Thus this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80A5 mg FDC compared with low dose T40A5 mg FDC in Japanese patients with essential hypertension In this trial a multi-centre randomised double-blind double-dummy active-controlled parallel group comparison method is employed
In the overseas 4x4 factorial design trial a clinically meaningful difference of the blood pressure lowering effect between T80A5 mg free combination and T40A5 mg free combination was shown U07-3503-02 But the sponsor has no data that verifies this difference in Japanese patients
Thus this clinical trial is being conducted to investigate the antihypertensive effect and safety of high dose T80A5 mg FDC compared with low dose T40A5 mg FDC in Japanese patients with essential hypertension In this trial a multi-centre randomised double-blind double-dummy active-controlled parallel group comparison method is employed
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