Clinical trial NCT00385931: Efficacy and Safety of Valsartan and the Combination of Valsartan and Simvastatin
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Hypercholesterolemia
Dyslipidemia
Keywords: Hypertension
high cholesterol
valsartan
simvastatin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 412
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline in ambulatory systolic blood pressure at 12 weeks
Secondary outcomes:
measure: 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
measure: Safety and tolerability
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: