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

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ClinicalTrials.gov Identifier: NCT00415623
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : December 9, 2008
Last Update Posted : December 9, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2007
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Amlodipine 5mg Drug: Amlodipine
Amlodipine 5mg/ day
Experimental: Amlodipine 10mg Drug: Amlodipine
Amlodipine 10mg/ day



Primary Outcome Measures :
  1. Change in Systolic Blood Pressure (SBP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]

Secondary Outcome Measures :
  1. Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8 [ Time Frame: Week 8 ]
  2. 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 ]
  3. 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 ]
  4. Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg [ Time Frame: Baseline, Week 4 and Week 8 ]
  5. 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 ]
  6. 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 ]
  7. Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8 [ Time Frame: Week 6 and Week 8 ]
  8. Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8 [ Time Frame: Baseline to Week 8 ]
  9. Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg [ Time Frame: Baseline, Week 4, and Week 8 ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00415623     History of Changes
Other Study ID Numbers: A0531085
First Posted: December 25, 2006    Key Record Dates
Results First Posted: December 9, 2008
Last Update Posted: December 9, 2008
Last Verified: December 2008

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