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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
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, high cholesterol, valsartan, simvastatin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 9, 2006
Last Updated
November 7, 2011
Sponsor
Novartis
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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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