NCT00241124

Brief Summary

A study comparing the antihypertensives Valsartan and Lisinporil when doses are in the morning and comparing a morning dose of Valsartan with an evening dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,099

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Apr 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

April 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

1.2 years

First QC Date

October 14, 2005

Last Update Submit

November 22, 2011

Conditions

Hypertension

Keywords

hypertensionvalsartanmorning/evening dosinglisinopril

Outcome Measures

Primary Outcomes (2)

  • Average 24 hour blood pressure less than 130/80 mmHg after 26 weeks

  • Change from baseline in systolic 24 hour blood pressure after 12 weeks

Secondary Outcomes (5)

  • Change from baseline manual blood pressure and pulse pressure after 26 weeks

  • Change from baseline markers of endothelial function, fibrosis, and other blood measurements of hypertension after 12 and 26 weeks

  • Changes in ambulatory blood pressure measurements at various timepoints up to 26 weeks

  • Change from baseline heart size after 26 weeks

  • Adverse events, serious adverse events, laboratory values, physical examinations, vital signs for up to 26 weeks

Interventions

valsartanDRUG
lisinoprilDRUG

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- Hypertension defined by a MSSBP \>=150 mmHg (untreated patients) or patients on current anti-hypertensive treatment who remain uncontrolled (i.e. MSSBP \>140 mmHg)
  • Randomisation mean 24h blood pressure above 130/80 mmHg
  • In addition the patients must fulfill, at least, one of the following criteria:
  • Controlled type II Diabetes mellitus Hypercholesteremia, currently treated with lipid-lowering drugs Metabolic syndrome MI, CABG or PTCA more than one year ago Stroke or transient ischemic cerebral attack more than one year ago Documented history of peripheral vascular disease, increased IMT, or carotid plaques Documented history of LVH Elderly \>65 years

You may not qualify if:

  • \- MSSBP \>=180 mmHg and/or MSDBP \>= 110 mmHg at any time from Visit 1 to Visit 3
  • Inability to discontinue all prior anti-hypertensive medications safely for a period of three weeks
  • Mandatory indication for any concomitant medication for coronary artery disease or any other disease that is not allowed during this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Investigative Centers, Germany

Location

Related Publications (1)

  • Zappe DH, Crikelair N, Kandra A, Palatini P. Time of administration important? Morning versus evening dosing of valsartan. J Hypertens. 2015 Feb;33(2):385-92. doi: 10.1097/HJH.0000000000000397.

    PMID: 25259546DERIVED

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 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

April 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

DE(1)