Non-Responder Study to Telmisartan 40mg
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Telmisartan 40 mg/HCTZ 12.5 mg (Drug); Telmisartan 40 mg (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Nippon Boehringer Ingelheim Co., Ltd.
Summary
The objective of this trial is to demonstrate that the fixed dose combination of telmisartan
40 mg a nd HCTZ 12. 5 mg is superior to the monocomponent of telmisartan (Micardis?,
Gliosartan?, Kinzal?, Ki nzalmono?, Predxal?, Pritor?, Samertan?, Telmisartan?) 40 mg in
patients with essential hypertension who fail to respond adequately to telmisartan
monotherapy.
Clinical Details
Official title: A Randomized, Double-Blind Study Comparing a Fixed Dose Combination of Telmisartan 40 mg Plus Hydrochlorothiazide 12.5 mg to Telmisartan 40 mg in Patients Who Fail to Respond Adequately to Treatment With Telmisartan 40 mg
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Primary Endpoint: The primary endpoint is the change from baseline in mean stated trough DBT
Secondary outcome: Change from baseline in seated trough SBP at the end of 8-week double-blind treatment Seated DBP control rate (seated trough DBP < 90 mmHg at the end of 8-week double-blind treatment)
Detailed description:
This is a multi-centre, randomised, double-blind, double-dummy, active-controlled,
parallel-group st udy 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 ope n-label run-in period with telmisartan (Micardis?) 40 mg
monotherapy to assess eligibility. The stud y will be terminated for those who have responded
to telmisartan (Micardis?) 40 mg monotherapy at th e end of 4-week open-label run-in period
with telmisartan (Micardis?) 40mg monotherapy (mean seated DBP < 90 mmHg). About 200
patients not responding adequately to telmisartan (Micardis?) 40 mg monot herapy will be
randomised and treated for 8 weeks with once-daily administration of either telmisart an
(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 m onotherapy.
Comparison(s):
For the primary comparison the change from baseline in mean stated trough DBP at the end of
8-week double-blind treatment will be expressed.
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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 hypertens ion,
primary aldosteronism, pheochromocytoma, etc.)
Locations and Contacts
Boehringer Ingelheim Investigational Site, Sapporo, Hokkaido 060-0003, Japan
Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo 163-6003, Japan
Additional Information
Ending date: August 2005
Last updated: April 3, 2008
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