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OpenTrials
Completed

NCT Number: NCT00385931

Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Valsartan and simvastatin

Drug

Primary outcomes

  1. Change from baseline in ambulatory systolic blood pressure at 12 weeks

Secondary outcomes

  1. 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

  2. Safety and tolerability

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Oct 11, 2006
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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