Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00153049
Status:
COMPLETED
Last Update Posted:
2013-11-08
First Post:
2005-09-09
Brief Title:
3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled 3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Essential Hypertension
Status:
COMPLETED
Status Verified Date:
2013-11
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:
1 To investigate the dose response of the combination therapy Telmisartan and Hydrochlorothiazide for the Japanese patients with Essential Hypertension
2 To compare this dose response with that in the US study
2 To compare this dose response with that in the US study
Detailed Description:
This is an 8-week multicentre randomised double-blind double-dummy placebo-controlled parallel group study utilizing all cells of a 3 x 3 factorial design Following Screening examinations and a 4-week Placebo Run-In Period 540 patients will be randomized to receive once-daily monotherapy with either telmisartan MICARDIS hydrochlorothiazide placebo or combination therapy with telmisartan and hydrochlorothiazide for 8 weeks Treatment Period
This study includes nine cells placebo telmisartan TEL 40 mg TEL 80 mg hydrochlorothiazide HCTZ 625 mg HCTZ 125 mg TEL 40 mgHCTZ 625 mg TEL 40 mgHCTZ 125 mg TEL 80 mgHCTZ 625 mg and TEL 80 mgHCTZ 125 mg
Study Hypothesis
The hypothesis is that the dose response model for the Japanese patient with essential hypertension which is constructed for the change of the supine diastolic blood pressure from the baseline value to end of treatment with the multiple regression analysis is similar to that in the US study 502204
Comparisons
The primary efficacy parameter will be the change from baseline in supine diastolic blood pressure at trough 24 hours post-dose at the last visit during the Double-Blind Period
The dose response surface model will be constructed The graphs of dose response surface will be generated based on the final model The model in this study will compare with that in US study from the perspective of including the same terms in the model
This study includes nine cells placebo telmisartan TEL 40 mg TEL 80 mg hydrochlorothiazide HCTZ 625 mg HCTZ 125 mg TEL 40 mgHCTZ 625 mg TEL 40 mgHCTZ 125 mg TEL 80 mgHCTZ 625 mg and TEL 80 mgHCTZ 125 mg
Study Hypothesis
The hypothesis is that the dose response model for the Japanese patient with essential hypertension which is constructed for the change of the supine diastolic blood pressure from the baseline value to end of treatment with the multiple regression analysis is similar to that in the US study 502204
Comparisons
The primary efficacy parameter will be the change from baseline in supine diastolic blood pressure at trough 24 hours post-dose at the last visit during the Double-Blind Period
The dose response surface model will be constructed The graphs of dose response surface will be generated based on the final model The model in this study will compare with that in US study from the perspective of including the same terms in the model
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