NCT00171067

Brief Summary

The purpose of this study is to compare if the combination of valsartan 320 mg/lisinopril 20 mg versus the monotherapies of lisinopril 40 mg or valsartan 320 mg will result in a greater decrease of urinary albumin excretion measured as urinary albumin/creatinine ratio (UACR) in the first morning urine of hypertensive subjects with previously diagnosed microalbuminuria (MAU).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jul 2004

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

July 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

2.8 years

First QC Date

September 10, 2005

Last Update Submit

May 15, 2017

Conditions

Hypertension

Keywords

Microalbuminuria, urinary albumin excretion, urinary albumin creatinine ratio, hypertension, valsartan, lisinopril, combination

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in urinary albumin excretion after 30 weeks

Secondary Outcomes (3)

  • Change from baseline in blood test for kidney function after 30 weeks

  • Reduction of urine albumin excretion in patients achieving blood pressures less than or equal to 130/80 mmHg

  • Change from baseline in circulating marker of inflammation after 30 weeks

Interventions

valsartanDRUG
lisinoprilDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with mild to moderate hypertension with a mean sitting diastolic blood pressure (MSDBP) \> 85 and \< 110 mmHg for non-treated patients. Previously treated patients with MSDBP \< 110 mmHg. Treated is defined as having taken medication until \< 2 days prior to Visit 1
  • Positive urine spot test with Micral dipstick (detection of urinary albumin concentration of at least 50 mg/l) at Visit 1 (day -21).
  • Confirmation of MAU of at least 2 out of 3 measurements determined in the first morning urine samples performed at Visit 1 day-21), Visit 2 (day -14) or Visit 3 (day -7). MAU is defined for male patients as urinary albumin creatinine ratio (UACR) \> 2.5 mg/mmol and \< 25.0 mg/mmol and for female patients as UACR \> 3.5 mg/mmol and \< 35.0 mg/mmol at both visits.

You may not qualify if:

  • Evidence of renal impairment as determined by any one of the following:
  • serum creatinine clearance \< 30 ml/min as determined by Cockroft and Gault formula \[Cockroft and Gault, 1976\] and/or
  • serum creatinine \> 1.25 x ULN at Visit 1,
  • a history of dialysis, or
  • a history of nephrotic syndrome.
  • Serum potassium values \<3.5 mmol/l or \>5.5 mmol/l at Visit 1
  • Any medical condition which might significantly alter the urinary excretion of albumin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (2)

  • Cooper TE, Teng C, Tunnicliffe DJ, Cashmore BA, Strippoli GF. Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers for adults with early (stage 1 to 3) non-diabetic chronic kidney disease. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD007751. doi: 10.1002/14651858.CD007751.pub3.

    PMID: 37466151DERIVED

  • Menne J, Farsang C, Deak L, Klebs S, Meier M, Handrock R, Sieder C, Haller H. Valsartan in combination with lisinopril versus the respective high dose monotherapies in hypertensive patients with microalbuminuria: the VALERIA trial. J Hypertens. 2008 Sep;26(9):1860-7. doi: 10.1097/HJH.0b013e32830508aa.

    PMID: 18698222DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanLisinopril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

July 1, 2004

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

May 17, 2017

Record last verified: 2017-05

Locations

CH(1)DE(1)