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A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00415623
First received: December 21, 2006
Last updated: December 5, 2008
Last verified: December 2008
History of Changes
  Purpose

The changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg


Condition Intervention Phase
Hypertension
 Drug: Amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient) [ Time Frame: Baseline to Week 6 and Week 8 ] [ Designated as safety issue: No ]
  • Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient) [ Time Frame: Baseline to Week 6 and Week 8 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg [ Time Frame: Baseline, Week 4 and Week 8 ] [ Designated as safety issue: No ]
  • Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Both Weeks 6 and 8 [ Time Frame: Week 6 and Week 8 ] [ Designated as safety issue: No ]
  • Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8 [ Time Frame: Week 6 and Week 8 ] [ Designated as safety issue: No ]
  • Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]
  • Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg [ Time Frame: Baseline, Week 4, and Week 8 ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: January 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amlodipine 5mg Drug: Amlodipine
Amlodipine 5mg/ day
Experimental: Amlodipine 10mg Drug: Amlodipine
Amlodipine 10mg/ day

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Untreated Hypertensive Patients: An systolic blood pressure of >=160 mmHg or diastolic blood pressure >=100mmHg.
  • Treated Hypertensive Patients: An systolic blood pressure of >=140 mmHg or diastolic blood pressure of >= 90 mmHg.
  • Patients with insufficient response to 5 mg of amlodipine in the screening period:Two successive systolic blood pressure measurements at Visit 4 (Week -2) and Visit 5 (Week 0 = baseline) >=140 mmHg
  • Patients with a screening treatment compliance rate >= 80%

Exclusion Criteria:

  • Subjects with secondary hypertension (renal disease, pheochromocytoma, and Cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic blood pressure of 110 mmHg or higher), and malignant hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00415623

Locations
Japan
Pfizer Investigational Site
Kasuya-gun, Fujuoka, Japan
Pfizer Investigational Site
Chikushino, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Pfizer Investigational Site
Koga, Fukuoka, Japan
Pfizer Investigational Site
Sapporo, Hokkaidou, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Iruma, Saitama, Japan
Pfizer Investigational Site
Koshigaya, Saitama, Japan
Pfizer Investigational Site
Adachi-ku, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00415623     History of Changes
Other Study ID Numbers: A0531085
Study First Received: December 21, 2006
Results First Received: October 16, 2008
Last Updated: December 5, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 16, 2013