Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient

Pfizer134 enrolled

Overview

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

NCT00415623 (protocol A0531085)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Hypertension

Interventions

AmlodipineDRUG

Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety * Patients who had a treatment compliance rate of at least 80% Exclusion Criteria: * The patient who met the discontinuation criteria in the preceding study A0531085

Locations (9)

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Outcomes

Primary Outcomes

Change in Systolic Blood Pressure From Baseline of the Preceding Study

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)

Time frame: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Change in Systolic Blood Pressure From Baseline of This Long-term Study

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)

Time frame: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Change in Diastolic Blood Pressure From Baseline of the Preceding Study

Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)

Time frame: Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Change in Diastolic Blood Pressure From Baseline of This Long-term Study

Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)

Time frame: Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value

Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg

Time frame: 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Data from ClinicalTrials.gov

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