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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00558064 |
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 |
MedlinePlus related topics: | High Blood Pressure |
ChemIDplus related topics: | Telmisartan Amlodipine Amlodipine besylate |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Filtered Trial for Amlodipine Non-Responder |
Estimated Enrollment: | 380 |
Study Start Date: | October 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
1) Pregnant or possibly pregnant 2) Nursing 3) Desire to become pregnant during study period 22. Drug or alcohol dependency 23. Complication of malignant tumour or a disease requiring immunosuppressants 24. Compliance of < 80% or > 120% during the run-in period 25. Receiving any investigational therapy within 3 months 26. Judged to be inappropriate by the investigator or the sub-investigator
Contact: Boehringer Ingelheim Study Coordinator | clintriage@boehringer-ingelheim.com |
Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Kiyose, Tokyo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Nagoya, Aichi, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Koriyama, Fukushima, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Matsudo, Chiba, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Koto-ku, Tokyo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Shizuoka, Shizuoka, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Sendai, Miyagi, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Saitama, Saitama, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Mito, Ibaraki, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Tsuchiura, Ibaraki, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Sapporo, Hokkaido, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Koshigaya, Saitama,, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Shinjyuku-ku, Tokyo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Shinjyuku-ku,Tokyo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Shinjuku-ku, Tokyo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Kashihara, Osaka, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Suita, Osaka,, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Okayama, Okayama,, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Takamatsu, Kagawa, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Itabashi-ku, Tokyo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Komoro, Nagano, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Higashiosaka, Osaka, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Shimoina-gun, Nagano, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Azumino, Nagano, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Kitaazumi-gun, Nagano, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Takaoka,Toyama, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Kobe, Hyogo, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Osaka, Osaka, Japan | |||||
Boehringer Ingelheim Investigational Site | Recruiting | ||||
Takaoka, Toyama, Japan |
Boehringer Ingelheim Pharmaceuticals |
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1235.13 |
First Received: | October 29, 2007 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00558064 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
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