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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00394745
• Date of registration: 31/10/2006
• Prospective Registration: No
• Primary sponsor: Novartis
• Public title: Effect of Valsartan on Lipid Subfractions in Hypertensive Patients With Metabolic Syndrome
• Scientific 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
• Date of first enrolment: November 2005
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00394745
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Novartis + 41 61 324 1111 Basel
• Affiliation: Novartis Basel+ 41 61 324 1111

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension

Metabolic Syndrome

Intervention(s)

Drug: Valsartan

Primary Outcome(s)

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

Secondary Outcome(s)

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.

To evaluate the effect of valsartan 320 mg on further lipid subfractions and enzymes related to the lipoprotein metabolism.

Secondary ID(s)

CVAL489ADE25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors