An Open-Label, Long-Term Study of Telmisartan Plus Amlodipine Fixed-Dose Combination
Information source: Boehringer Ingelheim Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: telmisartan40/amlodipine5 (Drug); telmisartan80/amlodipine5 (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Boehringer Ingelheim Pharmaceuticals Official(s) and/or principal investigator(s):
Boehringer Ingelheim, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals
Overall contact:
Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com
Summary
To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients
with essential hypertension who failed to control their BP with either monotherapy
Clinical Details
Official title: An Open-Label, Long-Term Study of Telmisartan Plus Amlodipine Fixed-Dose Combination
Study design: Treatment, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The safety of telmisartan plus amlodipine FDC during 1 year treatment will be assessed based on the following endpoints: Incidence of adverse events, Changes in BP and PR, Seated PR, Laboratory parameters, and ECG.
Secondary outcome: The secondary endpoints are:
To assess add on antihypertensive effect after 8 weeks of treatment with titrating up to T80/A5.
To discuss attenuation of antihypertensive effect.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Patients with essential hypertension
2. Outpatient
Exclusion Criteria:
Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the
double-blind treatment period in the "non-responder trials" Patients who have met any of
the exclusion criteria defined in the "non-responder trials"
Locations and Contacts
Boehringer Ingelheim Study Coordinator, Email: clintriage.rdg@boehringer-ingelheim.com
1235.16.001 Boehringer Ingelheim Investigational Site, Shinjyuku-ku,Tokyo, Japan; Recruiting
1235.16.002 Boehringer Ingelheim Investigational Site, Suita, Osaka, Japan; Recruiting
1235.16.003 Boehringer Ingelheim Investigational Site, Shinjuku-ku, Tokyo, Japan; Recruiting
1235.16.004 Boehringer Ingelheim Investigational Site, Chofu, Tokyo, Japan; Recruiting
1235.16.005 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan; Recruiting
1235.16.006 Boehringer Ingelheim Investigational Site, Nishi-ku, Hiroshima, Hiroshima, Japan; Recruiting
1235.16.007 Boehringer Ingelheim Investigational Site, Osaka, Osaka, Japan; Recruiting
Additional Information
Starting date: January 2008
Last updated: October 23, 2008
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