NCT00443456

Brief Summary

To investigate the safety and efficacy of the long-term use of amlodipine 10 mg in subjects who will be able to enter a long-term study after completing the parent study "A double-blind comparative study between amlodipine 5 mg and 10 mg in patients with essential hypertension for whom amlodipine 5 mg is insufficiently effective" (Protocol No.: A0531085).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started May 2007

Geographic Reach
1 country

9 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

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 9, 2009

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

1.1 years

First QC Date

March 2, 2007

Results QC Date

June 10, 2009

Last Update Submit

October 19, 2009

Conditions

Hypertension

Outcome Measures

Primary Outcomes (6)

  • Change in Systolic Blood Pressure From Baseline of the Preceding Study

    Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)

    Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Change in Systolic Blood Pressure From Baseline of This Long-term Study

    Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)

    Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Change in Diastolic Blood Pressure From Baseline of the Preceding Study

    Value at each observation time point minus value at Week 0 (Week 0 was defined as baseline of the preceding study A0531085: NCT00415623.)

    Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Change in Diastolic Blood Pressure From Baseline of This Long-term Study

    Value at each observation time point minus value at Week 8 (Week 8 was defined as baseline of this long-term study A0531086: NCT00443456.)

    Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value

    Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg

    8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Number of Subjects Whose Blood Pressure Reached Target Blood Pressure Reduction Value and Systolic Blood Pressure Had Decreased by 10 mmHg or More From Baseline in the Preceding Study

    Target blood pressure reduction value in accordance with Japanese Society of Hypertension Guidelines for the Management of Hypertension 2004: For \<= 64 years old: systolic blood pressure below 130 mmHg and diastolic blood pressure below 85 mmHg; For \>= 65 years old: systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg

    8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

Other Outcomes (6)

  • Change in Systolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

    Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Change in Systolic Blood Pressure From Baseline of This Long-term Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

    Week 8, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • Change in Diastolic Blood Pressure From Baseline of the Preceding Study in Treatment Groups With or Without Concomitant Antihypertensive Agent

    Week 0, 8 weeks, 10 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks and 52 weeks

  • +3 more other outcomes

Study Arms (1)

Single

EXPERIMENTAL
Drug: Amlodipine

Interventions

AmlodipineDRUG

Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks

Single

Eligibility Criteria

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

You may qualify if:

  • Patients who had completed the preceding study A0531085, Phase III study, who the investigator judged to be able to further treatment of long term administration in terms of efficacy and safety
  • Patients who had a treatment compliance rate of at least 80%

You may not qualify if:

  • The patient who met the discontinuation criteria in the preceding study A0531085

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, 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

Edogawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Setagaya-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Sumida-ku, Tokyo, 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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

May 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

October 28, 2009

Results First Posted

October 9, 2009

Record last verified: 2009-10

Locations

JP(9)