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

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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Amlodipine; Drug: Amlodipine

• Study Type: Interventional
• Enrollment (Actual): 305
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Amlodipine 5mg	Drug: Amlodipine; Amlodipine 5mg/ day; Drug: Amlodipine; Amlodipine 10mg/ day
Experimental: Amlodipine 10mg	Drug: Amlodipine; Amlodipine 5mg/ day; Drug: Amlodipine; Amlodipine 10mg/ day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Systolic Blood Pressure (SBP) From Baseline to Week 8	Mean change in the trough SBP	Baseline to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8	Mean change in the trough DBP	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"	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"	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	Week 8
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
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
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
Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg		Baseline, Week 4 and Week 8
Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg		Baseline, Week 4, and Week 8

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: December 21, 2006
• First Submitted That Met QC Criteria: December 22, 2006
• First Posted (Estimate): December 25, 2006

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Amlodipine
• Other Study ID Numbers: A0531085