Filtered Trial for Telmisartan 40mg Non-responder - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00550953

Purpose

The primary purpose of this study is to:

Demonstrate that a fixed-dose combination of telmisartan 40 mg plus amlodipine 5 mg is superior to telmisartan 40 mg alone in patients with essential hypertension and inadequately controlled with telmisartan 40 mg monotherapy.

Condition	Intervention	Phase
Hypertension	Drug: telmisartan+amlodipine Drug: telmisartan	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Official Title:	Filtered Trial for Telmisartan 40mg Non-responder

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:

Decrease in Seated Diastolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 Weeks ]

Secondary Outcome Measures:

Decrease in Seated Systolic Blood Pressure From Baseline to 8 Weeks [ Time Frame: Baseline and 8 weeks ]
Percentage of Patients With Seated Trough Diastolic Blood Pressure Less Than 90 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
Percentage of Patients With Seated Trough Systolic Blood Pressure Less Than 140 mmHg at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
Percentage of Patients Who Achieved an Adequate Response in Seated Trough Diastolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
Percentage of Patients Who Achieved an Adequate Response, Defining Seated Trough Systolic Blood Pressure Was <140 mmHg or Decreased From Reference Baseline by >=20 mmHg at 8 Weeks in Seated Trough Systolic Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]
Percentage of Patients With Optimal, Normal or High Normal Blood Pressure at 8 Weeks (0 Percent at Baseline) [ Time Frame: 8 weeks ]

Enrollment:	314
Study Start Date:	October 2007
Primary Completion Date:	July 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

Criteria

Inclusion Criteria:

Essential hypertensive patients who satisfying non-responder criteria
Male or Female
Age 20 years or older
Outpatient

Exclusion Criteria:

Taking four or more anti-hypertensive medications
Secondary hypertension
Mean seated diastolic blood pressure (DBP) > 114 mmHg and/or mean seated systolic blood pressure (SBP) > 200 mmHg at Visit 1, 2, 3, or 4, or mean seated DBP < 90 mmHg at Visit 3.
Sustained ventricular tachycardia or other clinically relevant cardiac arrhythmias
Congestive heart failure patients with the New York Heart Association (NYHA) functional class III-IV
History of myocardial infarction or cardiac surgery within last 6 months
History of coronary artery bypass graft or percutaneous coronary intervention (PCI) within last 3 months
History of unstable angina within last 3 months
Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of aortic or mitral valve
History of stroke or transient ischemic attack within last 6 months
History of sudden exacerbation of renal function with angiotensin II receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors, or patients with post-renal transplant or post-nephrectomy
Experienced characteristic symptoms of angioedema during treatment with ARBs or ACE inhibitors
Known hypersensitivity to any component of the investigational drug , or a known hypersensitivity to dihydropyridine -derived drugs
Hepatic and/or renal dysfunction
Diagnosed biliary atresia or cholestasis
Hyperkalemia
Dehydration
Sodium deficiency
Chronic administration of high doses of acidic nonsteroidal anti-inflammatory drugs (NSAIDs)
Patients who cannot change to the restricted administration and dosage during study period
Pre-menopausal women who meet any one of the following 1 - 3:
- Pregnant or possibly pregnant (1)
- Nursing (2)
- Desire to become pregnant during study period (3)
Drug or alcohol dependency
Complication of malignant tumour or a disease requiring immunosuppressants
Compliance of < 80% or > 120% during the run-in period
Receiving any investigational therapy within 3 months
Judged to be inappropriate by the investigator or the sub-investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550953

Locations

Japan
1235.14.002 Boehringer Ingelheim Investigational Site
Chofu, Tokyo, Japan
1235.14.003 Boehringer Ingelheim Investigational Site
Musashino, Tokyo, Japan
1235.14.005 Boehringer Ingelheim Investigational Site
Nishi-ku, Hiroshima, Hiroshima, Japan
1235.14.004 Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan
1235.14.001 Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00550953 History of Changes
Other Study ID Numbers:	1235.14
Study First Received:	October 26, 2007
Results First Received:	November 12, 2009
Last Updated:	February 8, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Benzoates
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents

Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 09, 2012