NCT00415623

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
305

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
7 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

December 9, 2008

Completed
Last Updated

February 11, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

December 21, 2006

Results QC Date

October 16, 2008

Last Update Submit

January 26, 2021

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

    Mean change in the trough SBP

    Baseline to Week 8

Secondary Outcomes (9)

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

    Baseline to Week 8

  • Combined Mean Change in SBP From Baseline to Week 6 and Week 8 (Mean by Patient)

    Baseline to Week 6 and Week 8

  • Combined Mean Change in DBP From Baseline to Week 6 and Week 8 (Mean by Patient)

    Baseline to Week 6 and Week 8

  • Number of Subjects Achieving the Target Blood Pressure Reduction Value at Week 8

    Week 8

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

    Week 6 and Week 8

  • +4 more secondary outcomes

Study Arms (2)

Amlodipine 5mg

ACTIVE COMPARATOR
Drug: Amlodipine

Amlodipine 10mg

EXPERIMENTAL
Drug: Amlodipine

Interventions

AmlodipineDRUG

Amlodipine 5mg/ day

Amlodipine 5mg

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Pfizer Investigational Site

Kasuya-gun, Fujuoka, Japan

Location

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Pfizer Investigational Site

Koga, Fukuoka, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Iruma, Saitama, Japan

Location

Pfizer Investigational Site

Koshigaya, Saitama, Japan

Location

Pfizer Investigational Site

Adachi-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Edogawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Sumida City, Tokyo, Japan

Location

Pfizer Investigational Site

Fukuoka, Japan

Location

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2006

First Posted

December 25, 2006

Study Start

January 1, 2007

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 11, 2021

Results First Posted

December 9, 2008

Record last verified: 2021-01

Locations

JP(14)