Efficacy and Safety of Valsartan and Amlodipine in Adults With Moderate, Inadequately Controlled Hypertension - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00523744

Purpose

This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension

Condition	Intervention	Phase
Hypertension	Drug: amlodipine and valsartan	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil Exforge

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg

Further study details as provided by Novartis:

Primary Outcome Measures:

Diastolic blood pressure change when using aml + val in patients not adequately responding (mean sitting diastolic blood pressure >= 90 mmHg) with aml+olmesartan. [ Time Frame: To 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SBP, pulse, heart rate, mean sitting systolic blood pressure < 140 mmHg and/or a mean sitting diastolic blood pressure < 90 mmHg) and responder rate (MSSBP < 140 mmHg or >= 20 mmHg decrease in mean sitting systolic blood pressure [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment:	256
Study Start Date:	August 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator amlodipine and valsartan	Drug: amlodipine and valsartan

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients (>=18 years)
Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
Patients with essential hypertension (diastolic blood pressure >=100 mmHg and <110 mmHg)

Exclusion Criteria:

Severe hypertension (diastolic blood pressure >=110 mmHg or systolic blood pressure >= 180 mmHg)
Pregnant or nursing women
Treated hypertensive patients with controlled hypertension under current therapy
A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523744

Locations

Germany
Novartis Investigative Site, , Germany
Schwerin, Germany
30 sites in Germany
tbd, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Sponsor GmbH

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVAA489ADE06
Study First Received:	August 30, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00523744
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

hypertension, valsartan, amlodipine

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Olmesartan medoxomil

Valsartan
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009