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OpenTrials
Completed

NCT Number: NCT00409851

One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sites in Germany, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL
  • VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg

Exclusion criteria

  • PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE
  • Other protocol-defined exclusion criteria may apply

Treatment and study plan

valsartan+amlodipine

Drug

Primary outcomes

  1. Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.

Secondary outcomes

  1. Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough

  2. Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough

  3. Sitting and standing pulse

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Dec 11, 2006
Registry last updated
Nov 8, 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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