An Eight-week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg vs. Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Telmisartan 80 mg and Hydrochlorothiazide 12.5 mg, Followed by a 52 Weeks Extension Study to Assess Long Term Safety of Telmisartan 80 mg and Amlodipine 5 mg and Hydrochlorothiazide 12.5 mg
Overview
- Phase
- Phase 3
- Intervention
- telmisartan + HCTZ
- Conditions
- Hypertension
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 132
- Locations
- 17
- Primary Endpoint
- Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This is a multi-centre, randomised, double-blind, active-controlled, parallel-group comparative trial to compare the fixed dose combination (FDC) of telmisartan 80 mg + hydrochlorothiazide 12.5 mg and amlodipine 5 mg (T80/A5/H12.5 mg) to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg (T80/H12.5 mg) in blood pressure lowering effect at week 8, the end of the double-blind period in essential hypertensive patients who fail to respond adequately to telmisartan 80 mg+ hydrochlorothiazide 12.5 mg.
Patients are assigned to one of the two groups after a 6-week open-label run-in period taking T80/H12.5 mg.
In addition the long-term safety of telmisartan 80 mg+ amlodipine 5 mg+ hydrochlorothiazide 12.5 mg will be evaluated in a 52-week extension period.
In the 52-week open label extension period patients who are assigned to the T80/A5/H12.5 mg group continue the T80/A5/H12.5 mg therapy, and patients who are assigned to the T80/ /H12.5 mg group change to the T80/A5/H12.5 mg therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
telmisartan + HCTZ + amlodipine
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Intervention: telmisartan + HCTZ
telmisartan + HCTZ + amlodipine
telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Intervention: amlodipine
telmisartan + HCTZ + placebo
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Intervention: placebo
telmisartan + HCTZ + placebo
telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
Intervention: telmisartan + HCTZ
Outcomes
Primary Outcomes
Change From Baseline in Mean Seated DBP at Trough After 8 Weeks of the Double-blind Period.
Time Frame: baseline and 8 weeks
Change from baseline in mean seated diastolic blood pressure (DBP) at trough (24-hour post dosing) after 8 weeks of the double-blind period. The results are presented as 'change' rather than 'reduction' i.e., reductions are expressed with negative values'. The 'adjusted mean' is shown as 'mean'.
Secondary Outcomes
- The Number of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 52 Weeks of Extension Period.(Reference baseline (week 0) and week 60 (end of extension period))
- The Percentage of Patients With DBP<90 mmHg and SBP<140 mmHg Blood Pressure at Trough After 8 Weeks of Double-blind Period.(Double-blind and 8 weeks)
- Change From Baseline in Mean Seated SBP at Trough After 8 Weeks of the Double-blind Period.(baseline and 8 weeks)
- Change From Baseline in Mean DBP Pressure at Trough After 52 Weeks of the Extension Period.(Reference baseline (week 0) and week 60 (end of extension period))
- Change From Baseline in Mean Seated SBP at Trough After 52 Weeks of the Extension Period.(Reference baseline (week 0) and week 60 (end of extension period))