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

This study has been completed.
Sponsor:
Information provided by:
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01127217
First received: May 19, 2010
Last updated: September 12, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: amlodipine/losartan
Drug: amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Change from baseline in MSSBP [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in MSSBP [ Time Frame: Baseline, Week 2 and 8 ] [ Designated as safety issue: No ]
  • Change from baseline MSDBP [ Time Frame: Baseline, Week 2, 6, and 8 ] [ Designated as safety issue: No ]
  • Blood pressure responder rate [ Time Frame: Baseline, Week 2, 6, 8 ] [ Designated as safety issue: No ]
    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.


Enrollment: 149
Study Start Date: May 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amlodipine/losartan Drug: amlodipine/losartan
amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
Other Name: amosartan
Active Comparator: amlodipine Drug: amlodipine
amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
Other Name: amodipin(amlodipine camsylate)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127217

Locations
Korea, Republic of
8 Sites
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01127217     History of Changes
Other Study ID Numbers: HM-ALOS-303
Study First Received: May 19, 2010
Last Updated: September 12, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Hanmi Pharmaceutical Company Limited:
amlodipine
losartan
hypertension
stage 2

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Losartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013