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Completed

NCT Number: NCT00220233

Olmesartan as an add-on to Amlodipine in Hypertension

This study is to test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with amlodipine alone

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Leipzig, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Without antihypertensive pre-treatment mean seated BP greater than 160/100 mmHg
  • Pre-treatment with amlodipine 5 or 10 mg: mean seated BP greater than or equal to 140/90 mmHg

Exclusion criteria

  • Secondary hypertension
  • Any serious disorder which may limit the ability to evaluate the efficacy or safety of the test drugs

Treatment and study plan

olmesartan medoxomil

Drug

Amlodipine

Drug

Hydrochlorothiazide

Drug

Primary outcomes

  1. Mean change in trough seated diastolic blood pressure

Secondary outcomes

  1. Mean change in trough seated systolic BP

  2. Mean change in daytime, nighttime and 24 hour ambulatory blood pressure

  3. Percent of patients achieving target blood pressure goal

  4. Safety and tolerability

Sponsors and collaborators

Lead sponsor

Sankyo Pharma Gmbh

Industry

Registry information

Official study title

Add-on Study of Olmesartan Medoxomil in Patients With Moderate to Severe Hypertension Not Achieving Target Blood Pressure on Amlodipine 5 mg Alone

Important dates

Study start
2005
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Dec 24, 2018

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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