Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient
NCT00443456
Last updated date
ABOUT THIS STUDY
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).
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
20-79 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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%
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- The patient who met the discontinuation criteria in the preceding study A0531085
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
HypertensionImpact of an IT-Based and Healthcare Professional Support Program on Patients With High Blood Pressure
NCT00374829
- Laval, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypertensionA Study Comparing the Response of Patients With Hypertension to Amlodipine or Amlodipine Plus Benazepril.
NCT00171366
- E. Hanover, New Jersey
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypertensionSTITCH (Simplified Therapeutic Intervention To Control Hypertension)
NCT00129909
- London, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HypertensionStudy on Internet Medical Models for the Management of Patients With Hypertension in China
NCT03527563
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Long Term Study Of Amlodipine 10mg With Hypertension For Whom Amlodipine 5mg Is Insufficient | |||
| Official Title ICMJE | Long-Term Study For Amlodipine 10mg In Patients With Essential Hypertension For Whom Amlodipine 5mg Is Insufficiently Effective | |||
| 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). | |||
| Detailed Description | NCT00415623 (protocol A0531085) | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Hypertension | |||
| Intervention ICMJE | Drug: Amlodipine
Two tablets of amlodipine 5 mg, Oral administration, Once daily for 44 weeks | |||
| Study Arms ICMJE | Experimental: Single
Intervention: Drug: Amlodipine | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 134 | |||
| Original Enrollment ICMJE | 130 | |||
| Actual Study Completion Date ICMJE | June 2008 | |||
| Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 20 Years to 79 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00443456 | |||
| Other Study ID Numbers ICMJE | A0531086 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | October 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||