Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00144222
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2005-09-02
Brief Title:
Combination of Telmisartan 40 mg Plus Hydrochlorothiazide HCTZ 125 mg vs Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan Monotherapy
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomized Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 40 mg Plus Hydrochlorothiazide 125 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg
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:
The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 125 mg is superior to the monocomponent of telmisartan Micardis Gliosartan Kinzal Kinzalmono Predxal Pritor Samertan Telmisartan 40 mg in patients with essential hypertension who fail to respond adequately to telmisartan monotherapy
Detailed Description:
This is a multi-centre randomised double-blind double-dummy active-controlled parallel-group study in patients with essential hypertension who fail to respond adequately to telmisartan Micardis 40 mg monotherapy
After a screening and a 2-week washout period screening period the patients will enter 4-week open-label run-in period with telmisartan Micardis 40 mg monotherapy to assess eligibility The study will be terminated for those who have responded to telmisartan Micardis 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan Micardis 40 mg monotherapy mean seated DBP 90 mmHg About 200 patients not responding adequately to telmisartan Micardis 40 mg monotherapy will be randomised and treated for 8 weeks with once-daily administration of either telmisartan Micardis 40 mg or a fixed dose combination of telmisartan 40 mg and HCTZ 125 mg double-blind treatment period
Study Hypothesis
The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 125 mg is superior to the monocomponent of telmisartan Micardis 40 mg in pat ient with essential hypertension who fail to respond adequately to telmisartan monotherapy
Comparisons
For the primary comparison the change from baseline in mean stated trough DBP at the end of the 8-week double-blind treatment will be expressed
After a screening and a 2-week washout period screening period the patients will enter 4-week open-label run-in period with telmisartan Micardis 40 mg monotherapy to assess eligibility The study will be terminated for those who have responded to telmisartan Micardis 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan Micardis 40 mg monotherapy mean seated DBP 90 mmHg About 200 patients not responding adequately to telmisartan Micardis 40 mg monotherapy will be randomised and treated for 8 weeks with once-daily administration of either telmisartan Micardis 40 mg or a fixed dose combination of telmisartan 40 mg and HCTZ 125 mg double-blind treatment period
Study Hypothesis
The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 125 mg is superior to the monocomponent of telmisartan Micardis 40 mg in pat ient with essential hypertension who fail to respond adequately to telmisartan monotherapy
Comparisons
For the primary comparison the change from baseline in mean stated trough DBP at the end of the 8-week double-blind treatment will be expressed
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