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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00385931

Enrollment

412

Registered

2006-10-11

Start date

2002-01-31

Completion date

2003-04-30

Last updated

2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypercholesterolemia, Hypertension

Keywords

Hypertension, high cholesterol, valsartan, simvastatin

Brief 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.

Interventions

DRUGValsartan and simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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 * serum CK more than twice ULN * sodium depletion * malignancy in preceding 5 years history of heart failure * myocardial infarction within the preceding 12 months * second or third degree heart block * concomitant refractory angina pectoris * symptomatic arrhythmia * valvular heart disease * Any condition/surgery that may alter absorption, distribution, metabolism, excretion of any drug (e.g. history of major gastrointestinal tract surgery, inflammatory bowel syndrome, pancreatic dysfunction, impaired renal or liver function)

Design outcomes

Primary

Measure	Time frame
Change from baseline in ambulatory systolic blood pressure at 12 weeks	—

Secondary

Measure	Time frame
Change from baseline at 12 weeks for ambulatory diastolic blood pressure, systolic and diastolic blood pressure (std cuff), day and nighttime blood pressures, biochemical markers of endothelial function & lipid levels	—
Safety and tolerability	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026