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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: October 31, 2006
Last updated: February 22, 2017
Last verified: February 2017
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 Intervention Phase
Hypertension Metabolic Syndrome Drug: Valsartan Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

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

Enrollment: 45
Study Start Date: November 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00394745

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

Additional Information:
Responsible Party: Novartis Identifier: NCT00394745     History of Changes
Other Study ID Numbers: CVAL489ADE25
Study First Received: October 31, 2006
Last Updated: February 22, 2017

Keywords provided by Novartis:
Hypertension, Metabolic Syndrome, lipid subfractions

Additional relevant MeSH terms:
Metabolic Syndrome X
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 processed this record on September 21, 2017