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Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00394745
Recruitment Status : Completed
First Posted : November 1, 2006
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.

Condition or disease Intervention/treatment Phase
Hypertension Metabolic Syndrome Drug: Valsartan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12 Week Treatment, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Valsartan 160-320 mg With Regard to Effects on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
Study Start Date : November 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Primary Outcome Measures :
  1. To evaluate the effect of valsartan 320 mg on small, dense low density lipoprotein (LDL) subfractions in hypertensive patients with metabolic syndrome.

Secondary Outcome Measures :
  1. To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.
  2. To evaluate the effect of valsartan 160-320 mg on blood pressure and pulse rate.
  3. To assess the safety and tolerability of valsartan 160-320mg.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female outpatients >= 18 years of age at Visit 1
  • Hypertension (systolic blood pressure >= 140 mmHg and < 170 mmHg and/or diastolic blood pressure >= 90 mmHg and < 105 mmHg
  • Elevated triglycerides
  • Metabolic syndrome as defined by Adult Treatment Panel III criteria

Exclusion Criteria:

  • MSSBP >= 170 mmHg and/or MSDBP >= 105 mmHg at any time between Visit 1 and Visit 2
  • Diabetes mellitus
  • Patients treated with lipid lowering drugs in the last 6 weeks prior to Visit 1
  • A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and peripheral artery disease, heart failure NYHA II - IV Other protocol-defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00394745

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Investigative Centers, Germany
Basel, Switzerland
Sponsors and Collaborators
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Study Director: Novartis + 41 61 324 1111 Basel Novartis Basel+ 41 61 324 1111

Additional Information:
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Responsible Party: Novartis Identifier: NCT00394745     History of Changes
Other Study ID Numbers: CVAL489ADE25
First Posted: November 1, 2006    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Keywords provided by Novartis:
Hypertension, Metabolic Syndrome, lipid subfractions
Additional relevant MeSH terms:
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Metabolic Syndrome
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action