Telmisartan80/HCTZ25 Versus Telmisartan80/HCTZ12.5 in Hypertension Not Responding to Telmisartan80/HCTZ12.5
|Hypertension||Drug: Fixed dose combination telmisartan 80 mg + HCTZ 25 mg Drug: Fixed dose combination telmisartan 80 mg + HCTZ 12.5 mg||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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 12.5 mg in Patients With Uncontrolled Hypertension Who Fail to Respond Adequately to Treatment With a Fixed Dose Combination of Telmisartan 80 mg Plus Hydrochlorothiazide 12.5 mg|
- Change from baseline in trough seated DBP [ Time Frame: 8 weeks ]
- Change from baseline in trough seated SBP [ Time Frame: 8 weeks ]
- Change from baseline in trough standing DBP and SBP [ Time Frame: 8 weeks ]
- The proportion of patients achieving DBP control (trough seated DBP<90 mmHg). [ Time Frame: 8 weeks ]
- The proportion of patients achieving DBP response (trough seated DBP<90 mmHg or trough seated DBP reduction from baseline ≥10 mmHg). [ Time Frame: 8 weeks ]
- The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥10 mmHg). [ Time Frame: 8 weeks ]
- The proportion of patients achieving SBP response (trough seated SBP<140 mmHg or trough seated SBP reduction from baseline ≥20 mmHg) [ Time Frame: 8 weeks ]
- The proportion of patients in trough seated BP categories: opt.: SBP<120 mmHg and DBP<80 mmHg., norm.: SBP<130 mmHg and DBP<85 mmHg and not optimal, high-normal: SBP<140 mmHg and DBP<90 mmHg and not optimal or normal, high: SBP ≥140 mmHg or DBP ≥90 mmHg [ Time Frame: 8 weeks ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
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 1,600 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 12.5 mg (T80/H12.5) 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 T80/H12.5. 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 mg(T80/H25) or T80/H12.5 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.
The trial hypothesis is that the reduction in seated trough DBP (i.e., 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 T80/H25 group compared with the T80/H12.5 group.
The efficacy and safety of the two trial treatments (T80/H25 versus T80/H12.5) will be compared. Trough blood pressure is the blood pressure 24 hours after the last dose of trial medication.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239369
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|Study Chair:||Boehringer Ingelheim Study Coordinator||BIL UK / Ireland|