Hypertension
Conditions
Brief summary
The objective of this trial is to demonstrate that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 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 12.5 mg (double-blind treatment period). Study Hypothesis: The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 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. Comparison(s): 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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Essential hypertensive patients who meet all the criteria as follows: * Mean seated DBP must be \>= 95 and \<= 114 mmHg at Visit 2 * Mean seated SBP must be \>= 140 and \<= 200 mmHg at Visit 2 * Mean seated DBP must be \>= 90 and \<= 114 mmHg at Visit 3 * Mean seated SBP must be \<= 200 mmHg at Visit 3
Exclusion criteria
* Patients taking 4 or more anti-hypertensive medications at Visit 1 * Patients with known or suspected secondary hypertension (renovascular hypertension, primary aldosteronism, pheochromocytoma, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean seated trough DBP after eight weeks of the double-blind treatment period | after 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Seated DBP control rate (seated trough DBP < 90 mmHg) | after 8 weeks |
| Seated DBP response rate V2 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP ≥ 10 mmHg) | after 8 weeks |
| Seated DBP response rate V3 (seated trough DBP < 90 mmHg and/or reduction from pseudo-baseline in seated trough DBP ≥ 10 mmHg) | after 8 weeks |
| Change in seated trough SBP | after 8 weeks |
| Seated SBP response rate V3 (seated trough SBP ≥ 140 mmHg at baseline and seated trough SBP < 140 mmHg and/or reduction from baseline in seated trough SBP ≥ 10 mmHg) | after 8 weeks |
| Change in trough pulse pressure | after 8 weeks |
| Plasma concentrations of Telmisartan and HCTZ | Day 56 |
| Seated SBP response rate V2 (seated trough SBP < 140 mmHg and/or reduction from pseudo-baseline in seated trough SBP ≥ 10 mmHg) | after 8 weeks |
Countries
Japan
Outcome results
None listed