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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00153049 |
Condition | Intervention | Phase |
---|---|---|
Hypertension |
Drug: Telmisartan Drug: Hydrochlorothiazide Drug: Telmisartan + Hydrochlorothiazide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Factorial Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Active-Controlled, 3 x 3 Factorial Trial of Telmisartan and Hydrochlorothiazide in Patients With Mild-to-Moderate Essential Hypertension |
Estimated Enrollment: | 540 |
Estimated Study Completion Date: | June 2005 |
This is an 8-week multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group study utilizing all cells of a 3 x 3 factorial design. Following Screening examinations and a 4-week Placebo Run-In Period, 540 patients will be randomized to receive once-daily monotherapy with either telmisartan (MICARDIS), hydrochlorothiazide, placebo, or combination therapy with telmisart and hydrochlorothiazide for 8 weeks (Treatment Period).
This study includes nine cells, placebo, telmisartan (TEL) 40 mg, TEL 80 mg, hydrochlorothiazide (HCTZ) 6.25 mg, HCTZ 12.5 mg, TEL 40 mg/HCTZ 6.25 mg, TEL 40 mg/HCTZ 12.5 mg, TEL 80 mg/HCTZ 6.25 mg, and TEL 80 mg/HCTZ 12.5 mg.
Study Hypothesis:
The hypothesis is that the dose response model for the Japanese patient with essential hypertension which is constructed for the change of the supine diastolic blood pressure from the baseline value to end of treatment with the multiple regression analysis, is similar to that in the US study 502.204.
Comparison(s):
The primary efficacy parameter will be the change from baseline in supine diastolic blood pressure at trough (24 hours post-dose) at the last visit during the Double-Blind Period.
The dose response surface model will be constructed. The graphs of dose response surface will be generated based on the final model. The model in this study will compare with that in US study from the perspective of including the same terms in the model.
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Essential hypertensive patients who meet the following criteria:
(The mean DBP and SBP values are calculated as the mean of the three supine measurements taken two minutes apart.)
Exclusion Criteria:
Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
Japan | |
Boehringer Ingelheim Investigational Site | |
Shinjyuku, Tokyo, Japan, 160-0022 | |
Boehringer Ingelheim Investigational Site | |
Inzai, Chiba, Japan, 270-1347 | |
Boehringer Ingelheim Investigational Site | |
Fukuoka, Fukuoka, Japan, 819-8551 | |
Boehringer Ingelheim Investigational Site | |
Suita, Osaka, Japan, 565-0853 | |
Boehringer Ingelheim Investigational Site | |
Mono-gun, Miyagi, Japan, 981-0503 | |
Boehringer Ingelheim Investigational Site | |
Sendai, Miyagi, Japan, 980-8660 | |
Boehringer Ingelheim Investigational Site | |
Shiroishi, Miyagi, Japan, 989-0228 | |
Boehringer Ingelheim Investigational Site | |
Shiroishi, Miyagi, Japan, 989-0231 | |
Boehringer Ingelheim Investigational Site | |
Osaka, Osaka, Japan, 530-0001 | |
Boehringer Ingelheim Investigational Site | |
Osaka, Osaka, Japan, 550-0014 | |
Boehringer Ingelheim Investigational Site | |
Koshigaya, Saitama, Japan, 343-0856 | |
Boehringer Ingelheim Investigational Site | |
Fukuoka, Fukuoka, Japan, 814-0163 | |
Boehringer Ingelheim Investigational Site | |
Isesaki, Gunma, Japan, 372-0001 | |
Boehringer Ingelheim Investigational Site | |
Annaka, Gunma, Japan, 379-0016 | |
Boehringer Ingelheim Investigational Site | |
Taya-gun, Gunma, Japan, 370-2132 | |
Boehringer Ingelheim Investigational Site | |
Kako-gun, Hyogo, Japan, 675-1112 | |
Boehringer Ingelheim Investigational Site | |
Kasuya-gun,Fukuoka, Japan, 811-2311 | |
Boehringer Ingelheim Investigational Site | |
Katsushika-ku,Tokyo, Japan, 124-0006 | |
Boehringer Ingelheim Investigational Site | |
Iida,Nagano, Japan, 395-8558 | |
Boehringer Ingelheim Investigational Site | |
Asahi,Chiba, Japan, 289-2151 | |
Boehringer Ingelheim Investigational Site | |
Ichinomiya, Aichi, Japan, 491-0851 | |
Boehringer Ingelheim Investigational Site | |
Kobe, Hyogo, Japan, 651-0072 | |
Boehringer Ingelheim Investigational Site | |
Setagun, Gunma, Japan, 377-0061 | |
Boehringer Ingelheim Investigational Site | |
Takasaki, Gunma, Japan, 370-0811 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. |
Study ID Numbers: | 502.439 |
Study First Received: | September 9, 2005 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00153049 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Clotrimazole Benzoates Miconazole Tioconazole Vascular Diseases |
Essential hypertension Telmisartan Angiotensin II Hydrochlorothiazide Hypertension |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Diuretics Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions |
Protease Inhibitors Membrane Transport Modulators Angiotensin II Type 1 Receptor Blockers Natriuretic Agents Antifungal Agents Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases |