NCT00394745

Brief Summary

The purpose of this study is to evaluate potential effects of valsartan on lipid subfractions and other parameters in lipid metabolism in patients with essential hypertension and metabolic syndrome.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_3 hypertension

Timeline
Completed

Started Nov 2005

Typical duration for phase_3 hypertension

Geographic Reach
2 countries

2 active sites

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

November 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

October 31, 2006

Last Update Submit

February 22, 2017

Conditions

HypertensionMetabolic Syndrome

Keywords

Hypertension, Metabolic Syndrome, lipid subfractions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

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

  • 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.

Interventions

ValsartanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis

Basel, Switzerland

Location

MeSH Terms

Conditions

HypertensionMetabolic Syndrome

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Essential

Study Officials

  • Novartis + 41 61 324 1111 Basel

    Novartis Basel+ 41 61 324 1111

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2006

First Posted

November 1, 2006

Study Start

November 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

February 24, 2017

Record last verified: 2017-02

Locations

DE(1)CH(1)