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Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00385931•Novartis

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

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
+9 more criteria

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Key Dates

Start Date

January 1, 2002

Primary Completion Date

April 1, 2003

Completion Date

April 1, 2003

Last Updated

November 9, 2023

Enrollment

412

ACTUAL participants

Conditions

HypertensionHypercholesterolemiaDyslipidemia

Interventions

Valsartan and simvastatin

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

Homocysteine and Early Diastolic Dysfunction in Newly Diagnosed Hypertension

Mobile Cued Adherence Therapy (mCAT) for Blood Pressure Medication

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Penn Medicine Healthy Heart