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Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

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ClinicalTrials.gov Identifier: NCT00443456
Recruitment Status : Completed
First Posted : March 6, 2007
Results First Posted : October 9, 2009
Last Update Posted : October 28, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine Phase 3

Detailed Description:
NCT00415623 (protocol A0531085)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
Study Start Date : May 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Drug: Amlodipine
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks




Primary Outcome Measures :
  1. Change in Systolic Blood Pressure From Baseline of the Preceding Study [ Time Frame: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]
  2. Change in Systolic Blood Pressure From Baseline of This Long-term Study [ Time Frame: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]
  3. Change in Diastolic Blood Pressure From Baseline of the Preceding Study [ Time Frame: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]
  4. Change in Diastolic Blood Pressure From Baseline of This Long-term Study [ Time Frame: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]
  5. Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value [ Time Frame: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]
  6. Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study [ Time Frame: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
  • Patients who had a treatment compliance rate of at least 80%

Exclusion Criteria:

  • The patient who met the discontinuation criteria in the preceding study A0531085

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): NCT00443456


Locations
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Japan
Pfizer Investigational Site
Chikushino, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Iruma, Saitama, Japan
Pfizer Investigational Site
Koshigaya, Saitama, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00443456     History of Changes
Other Study ID Numbers: A0531086
First Posted: March 6, 2007    Key Record Dates
Results First Posted: October 9, 2009
Last Update Posted: October 28, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents