Ignite Creation Date:
2024-05-05 @ 10:57 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01222520
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2010-10-15
Brief Title:
Telmisartan 80mg Non-responder Trial
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 80 mg Amlodipine 5 mg Fixed-dose Combination vs Telmisartan 80 mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg Monotherapy
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:
If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg an antihypertensive drug from different class should be started concomitantly
In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure DBP are equal or more than 95 mmHg the DBP control rate less than 90 mmHg after 8 weeks treatment of the telmisartan 80 mg monotherapy group 66 patients was 415 There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg
Thus this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination FDC drug of 2 antihypertensive agents with different pharmacological effects telmisartan 80 mg and amlodipine 5 mg T80A5 mg compared with telmisartan 80 mg T80 mg monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy In this trial a multi-centre randomised double-blind double-dummy active-controlled parallel group comparison method is employed
In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure DBP are equal or more than 95 mmHg the DBP control rate less than 90 mmHg after 8 weeks treatment of the telmisartan 80 mg monotherapy group 66 patients was 415 There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg
Thus this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination FDC drug of 2 antihypertensive agents with different pharmacological effects telmisartan 80 mg and amlodipine 5 mg T80A5 mg compared with telmisartan 80 mg T80 mg monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy 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