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OpenTrials
Completed

NCT Number: NCT00241137

A Study to Compare Treating Hypertension With Valsartan 160 MG to Valsartan 320 Mg

The purpose of this was to evaluate valsartan 320mg compared to valsartan 160 mg in terms of blood pressure reduction in a patient population of mild to moderate hypertensives

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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

  • • Male or female age between 18-80 years of age, inclusive
  • Diagnosed at enrollment (visits 2) to be mild to moderate hypertensive with a MSDBP >= 95 and =< 109 mmHg for non treated patients.
  • Previously treated patients should have a MSDBP =< 109 mmHg at visit 1 and a MSDBP >= 95 and =< 109 mmHg at visit 2.
  • Written informed consent to participate in the study prior to any study procedures
  • Ability to communicate and comply with all study requirements

Exclusion criteria

  • Severe hypertension (grade 3 of WHO classification; >= 110 mmHg diastolic and/or >= 180 mmHg systolic).
  • Malignant hypertension
  • Inability to discontinue all prior anti-hypertensive medications safely for a period of 2 weeks, as required by the protocol.
  • Known history of proteinuria (greater than 0.3 gram per day)
  • Female patients who are not either post-menopausal for one year or surgically sterile, and who are not using effective contraceptive methods such as barrier method with spermicidal or an intra-uterine device. Oral contraceptive use is not allowed.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1.
  • Transient ischemic cerebral attack during the last 12 months prior to Visit 1.

Treatment and study plan

valsartan

Drug

Primary outcomes

  1. Change from baseline diastolic blood pressure after 4 weeks

Secondary outcomes

  1. Change from baseline systolic blood pressure after 4 weeks

  2. Change from baseline diastolic and systolic blood pressure in patients with a diastolic blood pressure greater than or equal to 90 mmHg at randomization after 4 weeks

  3. Adverse events and serious adverse events at each study visit for 4 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2003
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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