Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146341
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-09-05
Brief Title:
Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 125 mg to Telmisartan 80 mg in Patients Failed in Telmisartan 80 mg
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
An Eight Week Randomized Double-Blind Double-Dummy Study Comparing a Fixed Dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 125mg to Telmisartan 80mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 80mg
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:
To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 125 mg is superior to telmisartan 80 mg alone in patients who fail to respond adequately to telmisartan 80 mg monotherapy in lowering seated trough diastolic blood pressure after eight weeks of treatment
Detailed Description:
This is a multi-centre prospective randomized double-blind parallel-group study in approximately 244 patients with a history of mild-to-moderate hypertensive who have been shown not to respond to telmisartan monotherapy
All patients will enter a one-week screening phase prior to starting the eight-week open-label T80 mg period At the end of four weeks only patients who fail to respond to T80 mg DBP 90 mm Hg will continue the treatment with T80 mg for another four weeks At the end of eight weeks only patients who fail to respond to T80 mg DBP 90 mm Hg will be randomized double-blind to receive either T80 mg alone or the fixed dose combination of T80 mg plus HCTZ 125 mg for eight weeks Seated BP will be taken 24 hours post-dose at each visit Labs ECG and physical examination will be done at screening at baseline and at the final visit
Study Hypothesis
The primary objective of the study showing that fixed dose combination is superior to telmisartan 80 mg alone will be tested using the hypotheses given below
H0 u T80H125 - uT80 0 mm Hg versus H1 uT80H125 - uT80 not equal 0 mm Hg where uT80H125 anduT80 represent the average reduction from baseline Visit 4 in trough seated DBP for the fixed dose combination and telmisartan 80 mg respectively
Testing of the null hypothesis will be performed using a two-sided test of significance at an a-level type-I error rate of 005
Comparisons
The primary efficacy endpoint will be the change from baseline in seated DBP 24 hours post-dose at the last visit during the double-blind treatment phase The pre-dose measurement on visit 4 will be viewed as the baseline measurement
All patients will enter a one-week screening phase prior to starting the eight-week open-label T80 mg period At the end of four weeks only patients who fail to respond to T80 mg DBP 90 mm Hg will continue the treatment with T80 mg for another four weeks At the end of eight weeks only patients who fail to respond to T80 mg DBP 90 mm Hg will be randomized double-blind to receive either T80 mg alone or the fixed dose combination of T80 mg plus HCTZ 125 mg for eight weeks Seated BP will be taken 24 hours post-dose at each visit Labs ECG and physical examination will be done at screening at baseline and at the final visit
Study Hypothesis
The primary objective of the study showing that fixed dose combination is superior to telmisartan 80 mg alone will be tested using the hypotheses given below
H0 u T80H125 - uT80 0 mm Hg versus H1 uT80H125 - uT80 not equal 0 mm Hg where uT80H125 anduT80 represent the average reduction from baseline Visit 4 in trough seated DBP for the fixed dose combination and telmisartan 80 mg respectively
Testing of the null hypothesis will be performed using a two-sided test of significance at an a-level type-I error rate of 005
Comparisons
The primary efficacy endpoint will be the change from baseline in seated DBP 24 hours post-dose at the last visit during the double-blind treatment phase The pre-dose measurement on visit 4 will be viewed as the baseline measurement
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