Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin
Primary Purpose
Hypertension, Hypercholesterolemia, Dyslipidemia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Valsartan and simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, high cholesterol, valsartan, simvastatin
Eligibility 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)
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00385931
Brief Title
Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypercholesterolemia, Dyslipidemia
Keywords
Hypertension, high cholesterol, valsartan, simvastatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
412 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Valsartan and simvastatin
Primary Outcome Measure Information:
Title
Change from baseline in ambulatory systolic blood pressure at 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
Safety and tolerability
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin
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