Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
---|---|
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00146341 |
To demonstrate that a fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg is superior to telmisartan 80 mg alone in patients, who fail to respond adequately to telmisartan 80 mg monotherapy, in lowering seated trough diastolic blood pressure after eight weeks of treatment.
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Telmisartan/HCTZ Drug: Telmisartan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety & Efficacy of MicardisPlus 80/12.5 |
Estimated Enrollment: | 340 |
Estimated Study Completion Date: | September 2006 |
This is a multi-centre, prospective, randomized, double-blind, parallel-group study in approximately 244 patients with a history of mild-to-moderate hypertensive who have been shown not to respond to telmisartan monotherapy.
All patients will enter a one-week screening phase prior to starting the eight-week open-label T80 mg period. At the end of four weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will continue the treatment with T80 mg for another four weeks. At the end of eight weeks, only patients who fail to respond to T80 mg (DBP >= 90 mm Hg) will be randomized, double-blind, to receive either T80 mg alone or the fixed dose combination of T80 mg plus HCTZ 12.5 mg for eight weeks. Seated BP will be taken 24 hours post-dose at each visit. Labs, ECG, and physical examination will be done at screening, at baseline and at the final visit.
Study Hypothesis:
The primary objective of the study, showing that fixed dose combination is superior to telmisartan 80 mg alone will be tested using the hypotheses given below.
H0: u T80/H12.5 - uT80 = 0 mm Hg versus H1: uT80/H12.5 - uT80 not equal 0 mm Hg, where uT80/H12.5 anduT80 represent the average reduction from baseline (Visit 4) in trough seated DBP for the fixed dose combination and telmisartan 80 mg, respectively.
Testing of the null hypothesis will be performed using a two-sided test of significance at an a-level (type-I error rate) of 0.05.
Comparison(s):
The primary efficacy endpoint will be the change from baseline in seated DBP 24 hours post-dose at the last visit during the double-blind treatment phase. The pre-dose measurement on visit 4 will be viewed as the baseline measurement.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women (last menstruation 1 year prior to start of screening):
Any woman:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
China | |
Ruijin Hospital, School of Medicine | |
Shanghai, China, 200025 | |
No. 1 Hospital Affiliated Nanjing | |
Nanjing, China, 210006 | |
No. 1 Hosp Affiliated to Med College | |
Zhejiang Province, China, 310003 | |
Peking Union Medical College Hospital | |
Beijing, China, 100730 | |
254 PLA Hospital | |
Tianjin, China, 300150 | |
Beijing Tiantan Hospital | |
Beijing, China, 100050 | |
Second Hospital Affiliated to Tianjin Med University | |
Tianjin, China, 300211 | |
Shanghai Changhai Hospital | |
Shanghai, China, 200433 | |
China-Japan Friendship Hospital | |
Beijing, China, 100029 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
Study ID Numbers: | 502.472 |
Study First Received: | September 5, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00146341 |
Health Authority: | China: State Food and Drug Administrative |
Vascular Diseases Telmisartan Angiotensin II Hydrochlorothiazide Hypertension |
Angiotensin II Type 1 Receptor Blockers Molecular Mechanisms of Pharmacological Action Angiotensin-Converting Enzyme Inhibitors Enzyme Inhibitors |
Cardiovascular Diseases Pharmacologic Actions Protease Inhibitors |