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Completed

NCT Number: NCT00942344

Efficacy and Safety of Amlodipine and Losartan in Patients With Essential Hypertension

The purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. The study will investigate the dose response relationship for the combinations and monotherapies.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

14 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 aged between 18 and 75
  • Patients with essential hypertension {95 mmHg ≤ sitDBP< 115 mmHg at the end of placebo run-in treatment period}

Exclusion criteria

  • Patients with mean sitSBP ≥ 200 mmHg
  • Patients with known hypersensitivity to Dihydropyridine or angiotensin II receptor blockers
  • Patients with secondary hypertension or suspected secondary hypertension
  • Patients with malignant hypertension
  • Patients who have received any medications with possible interactions with study drugs
  • Patients with uncontrolled diabetes
  • Patients with severe heart disease or severe cerebrovascular disease
  • Patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (ALT or AST)
  • Patients with a history of malignant disease
  • Patients with a history of autoimmune disease
  • Women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial
  • Patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Treatment and study plan

Amlodipine plus Losartan

Drug

amlodipine/losartan 5/50mg, 5/100mg, 10/50mg, 10/100mg

Other names: Amosartan

Amlodipine

Drug

amlodipine 5mg, 10mg

Losartan

Drug

Losartan 50mg, 100mg

Primary outcomes

  1. Average changes from baseline in sitDBP

    Time frame: Week 8

Secondary outcomes

  1. Average changes from baseline in sitDBP

    Time frame: Week 4

  2. Average changes from baseline in sitSBP

    Time frame: Week 4, 8

  3. Blood pressure responder rate

    Time frame: Week 4, 8

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An 8-week, Multicenter, Randomized, Double-blind, Factorial Phase II Study to Evaluate Dose-response Relationship of Amlodipine and Losartan Combination in Patients With Essential Hypertension.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 20, 2009
Registry last updated
Jul 20, 2009

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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