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

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00413413

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/amlodipine 80/5 mg Drug: Valsartan 80 mg Drug: Valsartan 160 mg	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 Valsartan 160mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160mg Monotherapy.

Further study details as provided by Novartis:

Primary Outcome Measures:

Diastolic blood pressure changes [ Time Frame: at baseline versus endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Systolic blood pressure changes [ Time Frame: from baseline compared to endpoint ] [ Designated as safety issue: No ]
Diastolic and Systolic blood pressure changes [ Time Frame: at baseline compared to various time points ] [ Designated as safety issue: No ]
Diastolic and systolic blood pressure response and control rates [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Safety and tolerability of valsartan 80 mg plus amlodipine 5 mg and valsartan 160 mg alone. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	919
Study Start Date:	January 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Valsartan 80 mg: Active Comparator	Drug: Valsartan 80 mg Valsartan 80 mg capsules (and matching placebo) for oral administration, once daily in the morning.
Valsartan 160 mg: Active Comparator	Drug: Valsartan 160 mg Valsartan 160 mg capsules (and matching placebo) for oral administration, once daily in the morning.
Valsartan/amlodipine 80/5 mg: Experimental	Drug: Valsartan/amlodipine 80/5 mg Valsartan/amlodipine 80/5 mg tablets (and matching placebo) for oral administration, once daily in the morning.

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: NCT00413413

Locations

China
Beijing ChaoYang Hospital, Affiliate of Capital University of Medical Sciences
Beijing, China, 100020
Beijing General Hospital of Beijing Military Region
Beijing, China, 100700
Beijing Hospital
Beijing, China, 100730
The people's Hospital of Liaoning Province
Shenyang, China, 110016
The First Affiliated Hospital of China Medical University
Shenyang, China, 110001
Second Hospital of Hebei University of Medical Sciences
Shijiazhuang, China, 050050
The People's Hospital of Hebei Provincial
Shijiazhuang, China, 050051
Second Military Medical University Affiliated Changzheng Hospital
Shanghai, China, 200003
Second Military Medical University Affiliated Changhai Hospital
Shanghai, China, 200433
Fudan University affiliated zhongshan hospital
Shanghai, China, 200032
The First Affiliated Hospital of Nanjing Medical University
Nanjing, China, 210029
The First Affiliated Hospital of Soochow University
Suzhou, China, 215006
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
The First Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, China, 310007
The Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, China, 310006
The First People's Hospital of Hangzhou
Hangzhou, China, 310006
Department of cardiology, Ruijin hospital;
Shanghai, China, 200025
Department of cardiology, Ruijin hospital
Shanghai, China, 200025
Southeast University Affiliated Zhong Da Hospital
Nanjing, China, 210009

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

Sponsor GmbH

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CVAA489A2316
Study First Received:	December 18, 2006
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00413413
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