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OpenTrials
Completed

NCT Number: NCT00241124

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Centers, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

valsartan

Drug

Lisinopril

Drug

Primary outcomes

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

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

Secondary outcomes

  1. Change from baseline manual blood pressure and pulse pressure after 26 weeks

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

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

  4. Change from baseline heart size after 26 weeks

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Oct 18, 2005
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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