An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
Official Title:	An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Telmisartan

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Percentage of Participants Who Experienced Adverse Events [ Time Frame: 52 weeks ]
An adverse event is defined as any untoward medical occurrence

Secondary Outcome Measures:

Change From Baseline in Seated Diastolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]
mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Change From Baseline in Seated Systolic Blood Pressure at Week 8 [ Time Frame: Baseline and week 8 ]
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure
Change From Baseline in Seated Diastolic Blood Pressure at Week 48 [ Time Frame: Baseline and week 48 ]
mean reduction from pseud-baseline (after the washout) in seated diastolic blood pressure
Change From Baseline in Seated Systolic Blood Pressure at Week 48 [ Time Frame: Baseline and week 48 ]
mean reduction from pseud-baseline (after the washout) in seated systolic blood pressure

Enrollment:	259
Study Start Date:	January 2008
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
1235.16.004 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan
1235.16.006 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
1235.16.007 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.16.002 Boehringer Ingelheim Investigational Site
Suita, Osaka, Japan
1235.16.003 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan
1235.16.001 Boehringer Ingelheim Investigational Site
Shinjyuku-ku,Tokyo, Japan
1235.16.005 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers:	1235.16
Study First Received:	February 8, 2008
Results First Received:	December 28, 2009
Last Updated:	March 2, 2010
ClinicalTrials.gov Identifier:	NCT00618774 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on March 18, 2010