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

Hypertension Clinical Trial

Official title:

A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415623
• Other study ID #: A0531085
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Amlodipine
Amlodipine 5mg/ day
• Amlodipine
Amlodipine 10mg/ day

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Adachi-ku	Tokyo
Japan	Pfizer Investigational Site	Chikushino	Fukuoka
Japan	Pfizer Investigational Site	Edogawa-ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Iruma	Saitama
Japan	Pfizer Investigational Site	Kasuya-gun	Fujuoka
Japan	Pfizer Investigational Site	Kitakyushu	Fukuoka
Japan	Pfizer Investigational Site	Koga	Fukuoka
Japan	Pfizer Investigational Site	Koshigaya	Saitama
Japan	Pfizer Investigational Site	Meguro-ku	Tokyo
Japan	Pfizer Investigational Site	Sapporo	Hokkaidou
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Setagaya-ku	Tokyo
Japan	Pfizer Investigational Site	Sumida	Tokyo
Japan	Pfizer Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Systolic Blood Pressure (SBP) From Baseline to Week 8	Mean change in the trough SBP	Baseline to Week 8
Secondary	Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8	Mean change in the trough DBP	Baseline to Week 8
Secondary	Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)	Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in SBP at Week 6" and "Change from baseline in SBP at Week 8"	Baseline to Week 6 and Week 8
Secondary	Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)	Arithmetic mean of Week 6 & Week 8 by patient for "Change from baseline in DBP at Week 6" and "Change from baseline in DBP at Week 8"	Baseline to Week 6 and Week 8
Secondary	Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old	Week 8
Secondary	Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old	Week 6 and Week 8
Secondary	Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old	Week 8
Secondary	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	Target blood pressure reduction value based on Japan Society of Hypertension Guidelines for the Management of Hypertension 2004: SBP below 130 mmHg and DBP below 85 mmHg for <=64 years old; SBP below 140 mmHg and DBP below 90 mmHg for >=65 years old	Week 6 and Week 8
Secondary	Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg		Baseline, Week 4 and Week 8
Secondary	Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg		Baseline, Week 4, and Week 8

External Links

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