An Open-Label, Long-Term Study of Telmisartan Plus Amlodipine Fixed-Dose Combination

This study is ongoing, but not recruiting participants.

Sponsored by:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00618774

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: telmisartan40/amlodipine5 Drug: telmisartan80/amlodipine5	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Telmisartan Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Long-Term Study of Telmisartan Plus Amlodipine Fixed-Dose Combination

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

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. [ Time Frame: 56 Weeks ]

Secondary Outcome Measures:

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. [ Time Frame: 8 Weeks and 56 Weeks ]

Estimated Enrollment:	200
Study Start Date:	January 2008
Estimated Primary Completion Date:	October 2009 (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

Criteria

Inclusion Criteria:

Patients with essential hypertension
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"

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618774

Locations

Japan
1235.16.001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1235.16.002 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1235.16.003 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.005 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.006 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
1235.16.004 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1235.16
Study First Received:	February 8, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00618774
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Telmisartan

Angiotensin II
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Membrane Transport Modulators
Angiotensin II Type 1 Receptor Blockers
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009