Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00413049

Purpose

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Condition	Intervention	Phase
Hypertension	Drug: Valsartan plus amlodipine Drug: Amlodipine	Phase III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Valsartan Amlodipine Amlodipine besylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Double Dummy, Comparing Efficacy and Safety of Valsartan/Amlodipine 80/5mg to Amlodipine 5mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5mg Monotherapy.

Further study details as provided by Novartis:

Primary Outcome Measures:

Diastolic blood pressure changes at baseline versus endpoint (Wk 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systolic blood pressure changes from baseline compared to endpoint (Wk 8) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Diastolic and systolic blood pressure changes from baseline to various time points [ Time Frame: baseline to various time points ] [ Designated as safety issue: No ]
Diastolic and systolic blood pressure response and control rates [ Time Frame: during treatment period ] [ Designated as safety issue: No ]
Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and amlodipine 5 mg alone. [ Time Frame: during treatment period ] [ Designated as safety issue: No ]

Enrollment:	698
Study Start Date:	January 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
valsartan/amlodipine 80/5 mg: Experimental	Drug: Valsartan plus amlodipine Valsartan/amlodipine 80/5 mg o.d.
amlodipine 5 mg: Active Comparator	Drug: Amlodipine Amlodipine 5 mg o.d.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients >= 18 years and < 86 years
Patients with essential diastolic hypertension
At visit 1, the patient must have mean sitting diastolic blood pressure >= 95 mmHg and < 10 mmHg
patients treated with antihypertensive medication must have a mean sitting diastolic blood pressure < 100 mmHg
At visit 2, patients must have a mean sitting diastolic blood pressure of >= 95 mmHg and < 100 mmHg
At visit 3, patients must have a mean sitting diastolic blood pressure of >= 90 mmHg and < 110 mmHg

Exclusion Criteria:

Severe hypertension >= 180/110 mmHg
Known or suspected contraindications, including a history of allergy or hypersensitivity to valsartan or amlodipine or to other drugs with similar chemical structures
Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2
History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or other types of revascularization
Malignant hypertension
All patients with Type I diabetes and those patients with Type 2 diabetes who are not well controlled based on the investigator's clinical judgment
Pregnant or nursing women
History of heart failure
Angina pectoris
Second or third degree heart block
Life threatening or symptomatic arrhythmias
Clinically significant valvular heart disease
Evidence of a secondary form of hypertension
Known or moderate malignant retinopathy
Evidence of hepatic disease
Evidence of renal impairment Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413049

Locations

China
Zhongshan hospital affiliated Fudan University
Shanghai, China, 200032
People's hospital affiliated Beijing University
Beijing, China, 100044
The first hospital affiliated Fujian medical University
Fuzhou, China, 350005
Union hospital affiliated Fujian medical University
Fuzhou, China, 350001
The second hospital affiliated Jiangxi medical school
Nanchang, China, 330006
The third Xiangya hospital of central south University
Changsha, China, 410003
China-Japan Friendship Hospital
Beijing, China, 100029
The third hospital affiliated the third military Medical University
Chongqing, China, 400042
The first hospital affiliated school of medical of Xi'an Jiaotong University
Xi'an, China, 710061
The sixth people's hospital of Shanghai
Shanghai, China, 200233
Institute of Hypertension, Ruijin Hospital
Shanghai, China, 200025
The first hospital affiliated the third military Medical University
Chongqing, China, 400038

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Sponsor GmbH

More Information

Responsible Party:	Novartis Pharmaceuticals ( Novartis Medical Director )
Study ID Numbers:	CVAA489A2315
Study First Received:	December 18, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00413049
Health Authority:	China: State Food and Drug Administration; United States: Food and Drug Administration

Keywords provided by Novartis:

Hypertension, valsartan, amlodipine, high blood pressure

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension

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 14, 2009