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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00558064 |
Purpose
To demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to amlodipine 5 mg alone in patients with essential hypertension and inadequately controlled with amlodipine 5 mg monotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: telmisartan+amlodipine Drug: amlodipine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Filtered Trial for Amlodipine Non-Responder |
| Enrollment: | 531 |
| Study Start Date: | October 2007 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Pre-menopausal women who meet any one of the following 1) - 3):
Contacts and Locations| Japan | |
| 1235.13.004 Boehringer Ingelheim Investigational Site | |
| Koriyama, Fukushima, Japan | |
| 1235.13.005 Boehringer Ingelheim Investigational Site | |
| Matsudo, Chiba, Japan | |
| 1235.13.008 Boehringer Ingelheim Investigational Site | |
| Koto-ku, Tokyo, Japan | |
| 1235.13.022 Boehringer Ingelheim Investigational Site | |
| Shizuoka, Shizuoka, Japan | |
| 1235.13.002 Boehringer Ingelheim Investigational Site | |
| Sendai, Miyagi, Japan | |
| 1235.13.019 Boehringer Ingelheim Investigational Site | |
| Sendai, Miyagi, Japan | |
| 1235.13.025 Boehringer Ingelheim Investigational Site | |
| Saitama, Saitama, Japan | |
| 1235.13.026 Boehringer Ingelheim Investigational Site | |
| Mito, Ibaraki, Japan | |
| 1235.13.020 Boehringer Ingelheim Investigational Site | |
| Tsuchiura, Ibaraki, Japan | |
| 1235.13.001 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.007 Boehringer Ingelheim Investigational Site | |
| Koshigaya, Saitama,, Japan | |
| 1235.13.010 Boehringer Ingelheim Investigational Site | |
| Shinjyuku-ku, Tokyo, Japan | |
| 1235.13.011 Boehringer Ingelheim Investigational Site | |
| Shinjyuku-ku,Tokyo, Japan | |
| 1235.13.012 Boehringer Ingelheim Investigational Site | |
| Takaoka, Toyama, Japan | |
| 1235.13.014 Boehringer Ingelheim Investigational Site | |
| Kashihara, Osaka, Japan | |
| 1235.13.015 Boehringer Ingelheim Investigational Site | |
| Suita, Osaka,, Japan | |
| 1235.13.016 Boehringer Ingelheim Investigational Site | |
| Okayama, Okayama,, Japan | |
| 1235.13.017 Boehringer Ingelheim Investigational Site | |
| Takamatsu, Kagawa, Japan | |
| 1235.13.027 Boehringer Ingelheim Investigational Site | |
| Koriyama, Fukushima, Japan | |
| 1235.13.009 Boehringer Ingelheim Investigational Site | |
| Kiyose, Tokyo, Japan | |
| 1235.13.042 Boehringer Ingelheim Investigational Site | |
| Shinjuku-ku, Tokyo, Japan | |
| 1235.13.003 Boehringer Ingelheim Investigational Site | |
| Koriyama, Fukushima, Japan | |
| 1235.13.023 Boehringer Ingelheim Investigational Site | |
| Higashiosaka, Osaka, Japan | |
| 1235.13.029 Boehringer Ingelheim Investigational Site | |
| Takamatsu, Kagawa, Japan | |
| 1235.13.032 Boehringer Ingelheim Investigational Site | |
| Takamatsu, Kagawa, Japan | |
| 1235.13.036 Boehringer Ingelheim Investigational Site | |
| Shimoina-gun, Nagano, Japan | |
| 1235.13.037 Boehringer Ingelheim Investigational Site | |
| Azumino, Nagano, Japan | |
| 1235.13.038 Boehringer Ingelheim Investigational Site | |
| Kitaazumi-gun, Nagano, Japan | |
| 1235.13.018 Boehringer Ingelheim Investigational Site | |
| Sendai, Miyagi, Japan | |
| 1235.13.039 Boehringer Ingelheim Investigational Site | |
| Takaoka,Toyama, Japan | |
| 1235.13.041 Boehringer Ingelheim Investigational Site | |
| Kobe, Hyogo, Japan | |
| 1235.13.040 Boehringer Ingelheim Investigational Site | |
| Osaka, Osaka, Japan | |
| 1235.13.021 Boehringer Ingelheim Investigational Site | |
| Itabashi-ku, Tokyo, Japan | |
| 1235.13.035 Boehringer Ingelheim Investigational Site | |
| Komoro, Nagano, Japan | |
| 1235.13.030 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.024 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.028 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.031 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.033 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.034 Boehringer Ingelheim Investigational Site | |
| Sapporo, Hokkaido, Japan | |
| 1235.13.013 Boehringer Ingelheim Investigational Site | |
| Nagoya, Aichi, Japan | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 1235.13 |
| Study First Received: | October 29, 2007 |
| Last Updated: | April 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00558064 History of Changes |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
|
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Calcium Channel Blockers Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Protease Inhibitors |
Amlodipine Angiotensin II Type 1 Receptor Blockers Membrane Transport Modulators Therapeutic Uses Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Telmisartan Hypertension |