A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
NCT00415623
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- 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%
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient | |||
Official Title ICMJE | A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective | |||
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 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Hypertension | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 305 | |||
Original Enrollment ICMJE | 500 | |||
Actual Study Completion Date ICMJE | October 2007 | |||
Actual Primary Completion Date | October 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years to 79 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Japan | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00415623 | |||
Other Study ID Numbers ICMJE | A0531085 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | December 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |