NCT00171327

Brief Summary

Patients with mild to moderate hypertension, dyslipidemia (imbalanced blood lipids) and decreased vascular dilatation, receiving a cholesterol lowering diet were given either valsartan or fluvastatin for 8 weeks. At week 8 all patients were administered a combination treatment with valsartan 160 mg and fluvastatin 80 mg.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

September 12, 2005

Last Update Submit

November 7, 2011

Conditions

HypertensionDyslipidemia

Keywords

arterial hypertensiondyslipidemiavalsartanfluvastatin

Outcome Measures

Primary Outcomes (2)

  • Percent change from baseline in brachial artery flow-mediated vasodilation after 8 weeks

  • Percent change from baseline in brachial artery flow-mediated vasodilation after 16 weeks compared to 8 weeks

Secondary Outcomes (3)

  • Percent change from baseline in low density lipoprotein cholesterol, total cholesterol, and triglycerides

  • Evaluating blood pressure effect on endothelial function

  • Evaluating total cholesterol effect on endothelial function

Interventions

valsartan, fluvastatinDRUG

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arterial hypertension
  • Dyslipidemia
  • Cholesterol lowering diet

You may not qualify if:

  • Constant antihypertensive treatment
  • Diabetes mellitus
  • Myocardial infarction or stroke in the previous 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Moscow, Russia

Location

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

ValsartanFluvastatin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

July 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

RU(1)