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

NCT ID: NCT00415623

Last Updated: 2021-02-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

Brief Summary

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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

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Amlodipine 5mg

Group Type ACTIVE_COMPARATOR

Amlodipine

Intervention Type DRUG

Amlodipine 5mg/ day

Amlodipine 10mg

Group Type EXPERIMENTAL

Amlodipine

Intervention Type DRUG

Amlodipine 10mg/ day

Interventions

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Amlodipine

Amlodipine 5mg/ day

Intervention Type DRUG

Amlodipine

Amlodipine 10mg/ day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kasuya-gun, Fujuoka, Japan

Site Status

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Koga, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Iruma, Saitama, Japan

Site Status

Pfizer Investigational Site

Koshigaya, Saitama, Japan

Site Status

Pfizer Investigational Site

Adachi-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Sumida City, Tokyo, Japan

Site Status

Pfizer Investigational Site

Fukuoka, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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A0531085

Identifier Type: -

Identifier Source: org_study_id

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