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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 21, 2014