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

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NCT00415623

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Kasuya-gun, Fujuoka, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-79 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00415623
Pfizer
Completed
A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient

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A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Amlodipine
    Amlodipine 5mg/ day
  • Drug: Amlodipine
    Amlodipine 10mg/ day
  • Active Comparator: Amlodipine 5mg
    Intervention: Drug: Amlodipine
  • Experimental: Amlodipine 10mg
    Intervention: Drug: Amlodipine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
305
October 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 79 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00415623
A0531085
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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[email protected]



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