NCT00171353

Brief Summary

One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P25-P50 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

Hypertension

Keywords

arterial hypertensionalbuminuriavalsartan

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in urine albumin excretion after 24 weeks

  • Change from baseline in an ultrasound measurement of blood flow after 24 weeks

Secondary Outcomes (1)

  • Effect of blood pressure changes on urine albumin excretion rate and blood vessel function

Interventions

valsartanDRUG

Eligibility Criteria

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

You may qualify if:

  • Arterial hypertension without previous regular treatment
  • Urinary albumin excretion rate above 30 mg / 24h
  • years old

You may not qualify if:

  • Reno-vascular arterial hypertension
  • Therapy resistant edema
  • Chronic heart failure, angina pectoris
  • Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

MeSH Terms

Conditions

HypertensionAlbuminuria

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesProteinuriaUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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

CH(1)