Efficacy/Safety of Amlodipine Plus Losartan Versus Amlodipine in Patients With Stage 2 Hypertension

September 12, 2010 updated by: Hanmi Pharmaceutical Company Limited

The Multicenter, Randomized, Double Blind Phase 3 Clinical Trial to Compare Efficacy and Safety of Combination of Amlodipine and Losartan Compared to Amlodipine Monotherapy in Patients With Stage 2 Hypertension

The purpose of this study is to evaluate the blood pressure lowering effects of an amlodipine/losartan combination treatment and amlodipine monotherapy for treatment of Stage 2 hypertensive patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 aged or over
  • Patients with blood pressure measured at Visit 1; MSSBP≤180mmHg and MSDBP≤110 mmHg if on anti-hypertensive drugs, 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg if not on anti-hypertensive drugs
  • Patients with blood pressure measured at Visit 2 were 160mmHg≤MSSBP≤199mmHg and 80mmHg≤MSDBP≤119mmHg

Exclusion Criteria:

  • Inability to stop all prior anti-hypertensive drugs safely during wash out period of 3 to 7 days
  • ≥ sitSBP 20mmHg or ≥ sitDBP 10mmHg of variation in three measurements from the reference arm selected at Screening
  • History of hypersensitivity to dihydropyridines, angiotensin II receptor blockers or thiazide diuretics
  • Secondary hypertension or suspected to be
  • Continuously took medicinal drugs that might affect blood pressure rather than anti-hypertensive drugs more than 3 months
  • Type 2 diabetes mellitus which is not controlled or with type 1 diabetes mellitus
  • History of severe neurovascular disease, severe heart disease
  • Known as moderate or malignant retinopathy.
  • Renal diseases; serum creatinine ≥ 2mg/dl
  • Hepatic diseases; increase in ALT or AST ≥ 2xUNL
  • Anuria
  • Hyponatremia/hypokalemia or hypercalcemia
  • Active Gout
  • Surgical or medical diseases which might significantly change ADME of medicines
  • History of malignant tumor
  • Autoimmune diseases
  • History of alcohol or drug abuse
  • Positive to pregnancy test, nursing mother, woman with an intention of pregnancy
  • Considered inappropriate to participate in the clinical trial with any reason, based on investigator's decision

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: amlodipine/losartan
Drug: amlodipine/losartan
amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
Other Names:
  • amosartan
Active Comparator: amlodipine
Drug: amlodipine
amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
Other Names:
  • amodipin(amlodipine camsylate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in MSSBP
Time Frame: Baseline, Week 6
Baseline, Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in MSSBP
Time Frame: Baseline, Week 2 and 8
Baseline, Week 2 and 8
Change from baseline MSDBP
Time Frame: Baseline, Week 2, 6, and 8
Baseline, Week 2, 6, and 8
Blood pressure responder rate
Time Frame: Baseline, Week 2, 6, 8
Rate of patients who achieved target blood pressure (MSSBP < 140 mmHg or MSDBP < 90 mmHg), or MSSBP decrease > 20 mmHg from baseline or MSDBP decrease > 10 mmHg from baseline.
Baseline, Week 2, 6, 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 12, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-ALOS-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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