Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00239369
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-10-13
Brief Title:
Telmisartan80HCTZ25 Versus Telmisartan80HCTZ125 in Hypertension Not Responding to Telmisartan80HCTZ125
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Prospective Randomised Study to Compare a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 25 mg With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 125 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 125 mg
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:
The primary objective of this trial is to demonstrate that a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 25 mg T80H25 is superior in reducing blood pressure after eight weeks compared with a fixed dose combination of telmisartan 80 mg plus hydrochlorothiazide 125 mg T80H125 in patients who fail to respond to six weeks treatment with T80H125
Detailed Description:
Adult patients with high blood pressure who are currently taking one two or three blood pressure treatments will be asked to take part in the study It is expected that about 1600 patients in seventeen countries will enter the screening part of the study and approximately 480 of these patients will be allocated to double-blind randomised study treatment The study will last for approximately fifteen weeks Patients will visit the study doctor five times for assessment After informed consent patients will start a screening period for four to ten days During the screening period patients must take their usual blood pressure treatment but will stop this by the date of the next visit If the patient is suitable for this study they will then start run-in treatment period with telmisartan 80 mg plus hydrochlorothiazide 125 mg T80H125 taken as a single tablet once per day for approximately six weeks
At the end of the run-in treatment period if the diastolic blood pressure DBP is below 90 mmHg the patient will not proceed as their blood pressure is already controlled by T80H125 If the DBP is 90 mmHg or greater they will start the randomised study treatment period and be randomly allocated to double-blind treatment with either telmisartan 80 mg plus hydrochlorothiazide 25 mgT80H25 or T80H125 taken as a single tablet once per day for eight weeks They will also receive a placebo tablet a dummy tablet which contains no active ingredient every day
They will visit the clinic four weeks and eight weeks later for assessment of their blood pressure and general health Their participation in the study is complete eight weeks after the start of the randomised treatment period
Study Hypothesis
The trial hypothesis is that the reduction in seated trough DBP ie seated trough DBP at the end of the randomised treatment period compared with the seated trough DBP at the start of the randomised treatment period will be greater in the T80H25 group compared with the T80H125 group
Comparisons
The efficacy and safety of the two trial treatments T80H25 versus T80H125 will be compared Trough blood pressure is the blood pressure 24 hours after the last dose of trial medication
At the end of the run-in treatment period if the diastolic blood pressure DBP is below 90 mmHg the patient will not proceed as their blood pressure is already controlled by T80H125 If the DBP is 90 mmHg or greater they will start the randomised study treatment period and be randomly allocated to double-blind treatment with either telmisartan 80 mg plus hydrochlorothiazide 25 mgT80H25 or T80H125 taken as a single tablet once per day for eight weeks They will also receive a placebo tablet a dummy tablet which contains no active ingredient every day
They will visit the clinic four weeks and eight weeks later for assessment of their blood pressure and general health Their participation in the study is complete eight weeks after the start of the randomised treatment period
Study Hypothesis
The trial hypothesis is that the reduction in seated trough DBP ie seated trough DBP at the end of the randomised treatment period compared with the seated trough DBP at the start of the randomised treatment period will be greater in the T80H25 group compared with the T80H125 group
Comparisons
The efficacy and safety of the two trial treatments T80H25 versus T80H125 will be compared Trough blood pressure is the blood pressure 24 hours after the last dose of trial medication
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