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OpenTrials
Completed

NCT Number: NCT00220220

Amlodipine as add-on to Olmesartan in Hypertension

Test the efficacy and safety of the combination of olmesartan and amlodipine in hypertensive patients whose blood pressure is not adequately controlled with olmesartan 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

Hamburg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mean sitting BP of greater than or equal to 140/90-115 mmHg and mean 24h dBP greater than or equal to 80 mmHg with at least 30% of daytime readings greater than 85 mmHg prior to randomization.

Exclusion criteria

  • Secondary hypertension of any aetiology;
  • Any serious disorders which may limit the ability to evaluate the efficacy or safety of the test drug(s);
  • History of myocardial infarction, unstable angina pectoris, percutaneous coronary intervention, congestive heart failure, hypertensive encephalopathy, stroke or TIA within the last 6 months.

Treatment and study plan

olmesartan medoxomil

Drug

Amlodipine

Drug

Primary outcomes

  1. Mean change in trough sitting diastolic blood pressure (dBP) assessed by conventional BP measurements after 8 weeks of double-blind treatment.

Secondary outcomes

  1. Mean change in trough sitting sBP and mean BP daytime, nighttime and 24h ABPM after 8 weeks of double-blind treatment.

  2. Responder rate, defined as number (%) of patients achieving BP goals during 8 weeks of double-blind treatment.

  3. Safety and tolerability

Sponsors and collaborators

Lead sponsor

Sankyo Pharma Gmbh

Industry

Registry information

Official study title

Efficacy and Safety of Amlodipine Used as add-on Therapy in Moderately to Severely Hypertensive Patients Not Adequately Controlled by Olmesartan Medoxomil 20 mg Monotherapy

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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