Clinical trial NCT00415623: A Comparative Study Between Amlodipine 10mg And 5mg With Hypertension For Whom 5mg Is Insufficient
Official title: A Double-Blind, Comparative Study Between Amlodipine 5mg And 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-25
Enrollment: 305
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic Blood Pressure (SBP) From Baseline to Week 8
timeFrame: Baseline to Week 8
Secondary outcomes:
measure: Change in Diastolic Blood Pressure (DBP) From Baseline to Week 8
timeFrame: Baseline to Week 8
measure: Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)
timeFrame: Baseline to Week 6 and Week 8
measure: Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)
timeFrame: Baseline to Week 6 and Week 8
measure: Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8
timeFrame: Week 8
measure: Combined Number of Subjects Achieving the Target Blood Pressure Reduction Value at Both Weeks 6 and 8
timeFrame: Week 6 and Week 8
measure: Number of Subjects Achieving the Target Blood Pressure Reduction Value and Whose SBP Decreased From Baseline by >= 10 mmHg at Week 8
timeFrame: Week 8
measure: 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
timeFrame: Week 6 and Week 8
measure: Trough Plasma Concentrations of Amlodipine -Amlodipine 5 mg
timeFrame: Baseline, Week 4 and Week 8
measure: Trough Plasma Concentrations of Amlodipine -Amlodipine 10 mg
timeFrame: Baseline, Week 4, and Week 8
Other outcomes:
Locations:
city: Kasuya-gun
country: Japan
facility: Pfizer Investigational Site
state: Fujuoka
city: Chikushino
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Koga
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaidou
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Iruma
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Koshigaya
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Adachi-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Sumida
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: