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Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes

NCT ID: NCT00241124

Last Updated: 2011-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1099 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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hypertension valsartan morning/evening dosing lisinopril

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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valsartan

Intervention Type DRUG

lisinopril

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- 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

Exclusion Criteria

* \- 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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Investigative Centers, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 25259546 (View on PubMed)

Other Identifiers

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CVAL489A2420

Identifier Type: -

Identifier Source: org_study_id