Comparison Of Morning And Evening Dosing Of Valsartan And Lisinopril In Patients With Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00241124

Purpose

A STUDY COMPARING THE ANTI-HYPERTENSIVES VALSARTAN AND LISINPORIL WHEN DOSES ARE IN THE MORNING AND COMPARING A MORNING DOSE OF VALSARTAN WITH AN EVENING DOSE

Condition	Intervention	Phase
Hypertension	Drug: valsartan Drug: lisinopril	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Double Dummy, Parallel Group, Active-Controlled Study To Evaluate The Effectiveness Of Morning Versus Evening Doses Of 320 Mg Valsartan Versus 40 Mg Lisinopril On The 24 Hour Blood Pressure Profile In Patients With Hypertension And Non-Insulin Dependent Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Lisinopril Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 Outcome Measures:

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

Estimated Enrollment:

990

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241124

Locations

Germany

Investigative Centers, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	CVAL489A2420
Study First Received:	October 14, 2005
Last Updated:	November 13, 2006
ClinicalTrials.gov Identifier:	NCT00241124 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Novartis:

hypertension
valsartan
morning/evening dosing
lisinopril

Study placed in the following topic categories:

Lisinopril
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Angiotensin-Converting Enzyme Inhibitors

Cardiovascular Agents
Antihypertensive Agents
Valsartan
Protease Inhibitors
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Physiological Effects of Drugs
Lisinopril
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Protective Agents
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 10, 2009