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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00394745
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Duration (Months): 19
• Patients Per Site: 22.5
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Nov 1, 2005
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1		Investigative Centers		Germany
2	Novartis	Basel		Switzerland

Sponsors and Collaborators

• Novartis

Investigators

• Study Director: Novartis + 41 61 324 1111 Basel, Novartis Basel+ 41 61 324 1111

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00394745
• Other Study ID Numbers: CVAL489ADE25
• First Posted: Nov 1, 2006
• Last Update Posted: Feb 24, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Novartis: Hypertension, Metabolic Syndrome, lipid subfractions
• Additional relevant MeSH terms: Hypertension; Metabolic Syndrome; Syndrome; Valsartan

Study Results

No Results Posted as of Feb 24, 2017