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OpenTrials
Completed

NCT Number: NCT00351130

Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

Essential hypertension is a widespread disease which affects one out of every three adults in the industrialized world. It contributes to cardiovascular disease development, a major and well established risk factor. A patient non compliant to drug therapy is recognized as one of the primary reasons for inadequate blood pressure control.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigative Centers, Germany

Loading trial locations.

Who can participate

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

Inclusion criteria

  • MSSBP> 140 mm Hg, and/or MSDBP> 90 mm Hg and currently treated with either valsartan 320 mg/ HCTZ 25 mg or amlodipine 10 mg/HCTZ 25 mg at end of core study

Exclusion criteria

  • Premature discontinuation in the core study or failure to comply with the core study protocol
  • Any patient that the investigator decides should not participate in the extension

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

valsartan

Drug

Amlodipine

Drug

Primary outcomes

  1. Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 22 weeks

Secondary outcomes

  1. Percentage of patients who reach BP goal, systolic <140 mmHg and diastolic <90 mmHg, after 14 and 22 weeks

  2. Adverse events after 22 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An 8 Week Extension to a Randomized, Double-blind, Parallel Group, Active-controlled, Multi-center, 14 Week Study to Evaluate the Effectiveness of a Valsartan Versus and Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 12, 2006
Registry last updated
Feb 24, 2017

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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