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OpenTrials
Completed

NCT Number: NCT00940667

Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Essential Hypertension

The purpose of this study is to evaluate of efficacy and safety of amlodipine plus losartan and amlodipine alone in patients with essential hypertension inadequately controlled on amlodipine monotherapy.

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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

13 sites in Korea

Seoul, Busan, Etc., South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients over 18 years of age
  • Essential hypertensive patients whose blood pressure is not controlled before the study (sit DBP ≥ 90 mmHg for drug-treated patient, sit DBP ≥ 95 mmHg for drug-naïve patient)
  • Non-responder to 4 weeks treatment of amlodipine 5 mg monotherapy (sit DBP ≥ 90mmHg)

Exclusion criteria

  • mean sit SBP ≥ 200 mmHg or mean sit DBP ≥ 120 mmHg at screening
  • mean sit SBP ≥ 180 mmHg or mean sit DBP ≥ 120 mmHg after 4 weeks of amlodipine 5 mg treatment
  • has a history of hypersensitivity to dihydropyridines or angiotensin II receptor blockers
  • Secondary hypertensive patient or suspected to be
  • Uncontrolled diabetes mellitus patients
  • Severe heart disease or severe neurovascular disease
  • Known as severe or malignant retinopathy
  • Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
  • History of malignancy tumor
  • History of autoimmune disease
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, has an intention on pregnancy
  • Considered by investigator as not appropriate to participate in the clinical study with othe reason

Treatment and study plan

Amlodipine plus Losartan

Drug

amlodipine/losartan 5/50mg q.d.

Other names: Amosartan

Amlodipine

Drug

amlodipine 5mg q.d.

Other names: Amodpine

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure

    Time frame: Week 8

Secondary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure

    Time frame: Week 4

  2. Change from baseline in mean sitting systolic blood pressure

    Time frame: Week 4, 8

  3. Responder rate

    Time frame: Week 4, 8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

A Phase III, 8-week, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Amlodipine 5mg+Losartan 50mg Versus Amlodipine 10mg in Patients With Essential Hypertension Not Controlled on Amlodipine Monotherapy

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 16, 2009
Registry last updated
Oct 12, 2016

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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