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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.305 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

305

Conditions

Hypertension

Interventions

AmlodipineDRUG

Amlodipine 5mg/ day

AmlodipineDRUG

Amlodipine 10mg/ day

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (14)

Pfizer Investigational Site

Kasuya-gun, Fujuoka, Japan

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Outcomes

Primary Outcomes

Change in Systolic Blood Pressure (SBP) From Baseline to Week 8

Mean change in the trough SBP

Time frame: Baseline to Week 8

Secondary Outcomes

Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8

Mean change in the trough DBP

Time frame: Baseline to Week 8

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"

Time frame: Baseline to Week 6 and Week 8

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"

Time frame: Baseline to Week 6 and Week 8

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

Time frame: Week 8

Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8

Time frame: Week 6 and Week 8

Data from ClinicalTrials.gov

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