A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00415623

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 III

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate

U.S. FDA Resources

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

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
Amlodipine 5mg: Active Comparator	Drug: Amlodipine Amlodipine 5mg/ day
Amlodipine 10mg: Experimental	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
Fukuoka, Japan
Japan, Fujuoka
Pfizer Investigational Site
Kasuya-gun, Fujuoka, Japan
Japan, Fukuoka
Pfizer Investigational Site
Koga, Fukuoka, Japan
Pfizer Investigational Site
Chikushino, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu, Fukuoka, Japan
Japan, Hokkaido
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Japan, Hokkaidou
Pfizer Investigational Site
Sapporo, Hokkaidou, Japan
Japan, Kanagawa
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Japan, Saitama
Pfizer Investigational Site
Koshigaya, Saitama, Japan
Pfizer Investigational Site
Iruma, Saitama, Japan
Japan, Tokyo
Pfizer Investigational Site
Sumida, Tokyo, Japan
Pfizer Investigational Site
Meguro-ku, Tokyo, Japan
Pfizer Investigational Site
Edogawa-ku, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Adachi-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

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

Study placed in the following topic categories:

Calcium, Dietary
Vascular Diseases
Essential hypertension
Amlodipine
Hypertension

Additional relevant MeSH terms:

Membrane Transport Modulators
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009