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

Phase 3

Completed

Conditions: Hypertension

Interventions: Drug: Amlodipine

Registration Number: NCT00415623

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

Brief 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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 305

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amlodipine 5mg	Amlodipine	-
Amlodipine 10mg	Amlodipine	-

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP) From Baseline to Week 8	Baseline to Week 8	Mean change in the trough SBP

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8	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
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8	Baseline to Week 8	Mean change in the trough DBP
Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)	Baseline to Week 6 and Week 8	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"
Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8	Week 6 and 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
Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8	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
Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)	Baseline to Week 6 and Week 8	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"
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
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	Week 6 and 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