Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin - Full Text View

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00385931

Purpose

This study will assess and compare the efficacy and safety of valsartan and the combination of valsartan and simvastatin in patients with high blood pressure and high cholesterol.

Condition	Intervention	Phase
Hypertension Hypercholesterolemia Dyslipidemia	Drug: Valsartan and simvastatin	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-centre Study to Evaluate the Effects of Valsartan and the Combination of Valsartan and Simvastatin on Blood Pressure (Ambulatory and Std Cuff) and on Biochemical Markers of Endothelial Function (hsCRP, MCP-1, Serum F2 Isoprostanes, PAI-1, tPA, PICP, PIIINP, MMP9, MMP1, TIMP 1), Safety and Tolerability

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure

Drug Information available for: Simvastatin Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary Outcome Measures:

Change from baseline at 12 weeks for ambulatory diastolic blood pressure, systolic and diastolic blood pressure (std cuff), day and nighttime blood pressures, biochemical markers of endothelial function & lipid levels
Safety and tolerability

Enrollment:	412
Study Start Date:	January 2002
Study Completion Date:	April 2003
Primary Completion Date:	April 2003 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female patients at least 50 years of age
Mild to moderate essential systolic hypertension (grades 1 and 2 WHO classification) defined as MSSBP ≥ 150 mmHg and <180mmHg
Simultaneous primary hypercholesterolemia or mixed dislipidemia (Fredrickson Types IIa and IIb) defined by LDL-C level ≥ 130 mg/dL and <190 mg/dL and triglyceride levels ≤ 400 mg/dL despite dietary therapy
Off medication at randomization

Exclusion Criteria:

Severe hypertension (grade 3 WHO classification
≥ 180 mm Hg systolic or ≥ 110 mm Hg (diastolic)
secondary form of hypertension
known Keith-Wagener Grade III or IV hypertensive retinopathy
history of hypertensive encephalopathy or cerebrovascular accident within the preceding 12 months
transient ischemic cerebral attack during the preceding 6 months
dyslipidemia secondary to other causes
Type 1 diabetes mellitus
Type 2 diabetes mellitus with poor glucose control
history of systemic inflammatory diseases
serum CK more than twice ULN
sodium depletion
malignancy in preceding 5 years history of heart failure
myocardial infarction within the preceding 12 months
second or third degree heart block
concomitant refractory angina pectoris
symptomatic arrhythmia
valvular heart disease
Any condition/surgery that may alter absorption, distribution, metabolism, excretion of any drug (e.g. history of major gastrointestinal tract surgery, inflammatory bowel syndrome, pancreatic dysfunction, impaired renal or liver function)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385931

Locations

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00385931 History of Changes
Other Study ID Numbers:	CVAS489A2301
Study First Received:	October 9, 2006
Last Updated:	November 7, 2011
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Hypertension
high cholesterol
valsartan
simvastatin

Additional relevant MeSH terms:

Hypercholesterolemia
Hypertension
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Valsartan
Hypolipidemic Agents
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Antihypertensive Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012