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OpenTrials
Completed

NCT Number: NCT00171535

Efficacy and Safety of Valsartan/Amlodipine Combination in Patients With Severe Hypertension

This study will assess the effectiveness and safety of different combination antihypertensive treatments in patients with severe hypertension

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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

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

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

Inclusion criteria

  • Patients with severe hypertension

Exclusion criteria

  • History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
  • Liver, kidney, or pancreas disease
  • Insulin dependent diabetes
  • Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Valsartan/amlodipine

Drug

Primary outcomes

  1. Adverse events and serious adverse events at each study visit for 6 weeks

Secondary outcomes

  1. Sitting and standing blood pressure measurements after 6 weeks

  2. Laboratory test data after 6 weeks

  3. Vital signs at each study visit for 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Study to Evaluate the Safety and Efficacy of Valsartan/Amlodipine Compared to Lisinopril/Hydrochlorothiazide Given Once Daily for 6 Weeks is Patients With Severe Hypertension

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
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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