Safety and Efficacy of Valsartan/Amlodipine Compared to Amlodipine in Patients With Essential Hypertension - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00437645

Purpose

This study is designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled [defined as mean sitting systolic blood pressure (MSSBP) ≥ 130 mmHg and ≤ 160 mmHg] on amlodipine 5 mg alone.

The study will evaluate the efficacy and tolerability of both treatment groups by providing data evaluating blood pressure lowering efficacy and the proportion of patients developing peripheral edema.

Condition	Intervention	Phase
Essential Hypertension	Drug: Valsartan/Amlodipine Drug: Amlodipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Efficacy, Tolerability, and Safety of Treatment With the Combination of Valsartan/Amlodipine 160/5 mg Compared to Amlodipine 10 mg in Patients With Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Alone

Resource links provided by NLM:

MedlinePlus related topics: Edema High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in mean sitting systolic blood pressure (MSSBP) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: No ]
Incidence of peripheral edema quantified as adverse event (AE) reported peripheral edema [ Time Frame: after 8-week treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in mean sitting diastolic blood pressure (MSDBP) [ Time Frame: after 8-week treatment ] [ Designated as safety issue: Yes ]
Change from baseline in MSSBP and MSDBP [ Time Frame: after 4 and 12 weeks of treatment ] [ Designated as safety issue: No ]
Systolic blood pressure responder rate (defined as MSSBP < 130 mmHg or ≥ 20 mmHg reduction from baseline) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
Proportion of patients who reach systolic blood pressure control (defined as MSSBP < 130mmHg) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]
Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients) [ Time Frame: at week 4, 8, and 12 ] [ Designated as safety issue: No ]

Enrollment:	1183
Study Start Date:	January 2007
Estimated Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Valsartan/Amlodipine 160/5 mg: Experimental	Drug: Valsartan/Amlodipine
Amlodipine 10 mg: Active Comparator	Drug: Amlodipine

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients ≥ 55 years of age
Patients with essential hypertension measured using a validated automated oscillometric device at Visit 1
Non-treated patients must have a MSSBP ≥140 mmHg and ≤ 160 mmHg
Patients pre-treated on monotherapy prior to Visit 1 must have MSSBP ≤ 160 mmHg
To be eligible for randomization at Visit 2 (Day 1) all patients must have a MSSBP ≥130 mmHg and ≤ 160 mmHg
No peripheral edema at Visit 2 (randomization)
Written informed consent to participate in this study prior to any study procedures

Exclusion Criteria:

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers, calcium channel blockers, or to drugs with similar chemical structures
Patients taking more than 1 antihypertensive medication at Visit 1
Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of pre-treated patients that require tapering down of anti-hypertensive treatments. For patients with previous antihypertensive medication that require a gradual downward titration, the tapering down should be done according to manufacturers instructions and last dose should be taken by week -2 prior to randomization
MSSBP >180mmHg or MSDBP >110 mmHg at any time between Visit 1 and Visit 2
Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, polycystic kidney disease, or pheochromocytoma
History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, myocardial infarction, percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) 12 months prior to Visit 1
History of heart failure Grade II - IV according to the NYHA classification
Second or third degree heart block with or without a pacemaker
Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia
Concomitant unstable angina pectoris
Clinically significant valvular heart disease
Patients with Type 1 diabetes mellitus
Patients with Type 2 diabetes mellitus who are not well controlled based on the investigator's judgment. It is recommended that Type 2 diabetic patients are adequately controlled and, if treated with medication, be on a stable dose of oral anti-diabetic medication for at least 4 weeks prior to Visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437645

Locations

Finland
Novartis Investigative Site, Finland
Joensuu, Finland, FI-80100
Germany

Sites in Germany, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Schrader J, Salvetti A, Calvo C, Akpinar E, Keeling L, Weisskopf M, Brunel P. The combination of amlodipine/valsartan 5/160 mg produces less peripheral oedema than amlodipine 10 mg in hypertensive patients not adequately controlled with amlodipine 5 mg. Int J Clin Pract. 2009 Feb;63(2):217-25.

Responsible Party:	External Affairs ( Novartis Pharmaceuticals )
Study ID Numbers:	CVAA489A2404
Study First Received:	February 16, 2007
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00437645 History of Changes
Health Authority:	United States: Food and Drug Administration; Finland: Finnish Medicines Agency

Keywords provided by Novartis:

Essential hypertension, blood pressure, edema, valsartan, amlodipine, combination treatment

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009