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OpenTrials
Completed

NCT Number: NCT01828359

The Efficacy and Safety Study of Anti-hypertension Combination Drug in Patients Uncontrolled With Monotherapy.

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and losartan/Hydrochlorothiazide combination treatment in patients with essential hypertension uncontrolled with losartan 100mg monotherapy.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

  • Quality assurance plan was implemented by site monitoring, including data validation and registry procedures and Source data verification to assess the accuracy, completeness by comparing the data to external data sources (medical records and paper case report forms).
  • Data dictionary contains the registry, including the source of the variable, coding information (MedDRA ver12.0), and normal ranges.
  • Statistical analysis were performed using SAS® Version 9.2, SAS institute, Cary, NC, USA

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 20 aged or over
  • Patients with blood pressure measured at Visit 1; 90mmHg≤MSDBP mmHg if on anti-hypertensive drugs, 95mmHg≤MSDBP mmHg if not on anti-hypertensive drugs
  • Patients with blood pressure measured at Visit 2 were 90mmHg≤MSDBP mmHg (non-responder to Losartan 100mg for 4-week treatment)

Exclusion criteria

  • Patients with too high Blood pressure

•≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening

  • History of hypersensitivity to CCB ,Angiotensin II receptor blockers or Sulfonamide.
  • Secondary hypertension or suspected to be

Treatment and study plan

Amosartan® tab

Drug

comparison of different combination of anti-hypertension drug

Other names: Amlodipine 5mg /Losartan 100mg

Cozaar® plus pro tab

Drug

comparison of different combination of anti-hypertension drug

Other names: Losartan 100mg/ HCTZ 12.5mg

Primary outcomes

  1. Change from baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

    Time frame: Baseline, Week 8

Secondary outcomes

  1. Change from baseline in MSDBP

    Time frame: Baseline, week 4

  2. Change from baseline Mean Seated Systolic Blood Pressure (MSSBP)

    Time frame: Baseline, Week 4 and 8

  3. Blood pressure responder rate

    Time frame: Baseline, Week 4 and 8

    Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg and MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

An Eight-week, Randomized, Double-blind Multicenter Study to Compare the Efficacy and Safety of Amosartan® Tab 5/100mg Versus Cozaar® Plus Pro Tab in Patients With Essential Hypertension Uncontrolled With Losartan 100mg Monotherapy

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 10, 2013
Registry last updated
Apr 10, 2013

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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