A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.

NCT00272961

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294-2041, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Resistant Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of resistant hypertension.

- A stable anti-hypertensive drug regimen for at least 30 days.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Sustained blood pressure greater than or equal to 180/120 mmHg.


- Required use of thigh cuff for blood pressure readings.


- Uncontrolled diabetes mellitus.

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Resistant HypertensionA Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
NCT00272961
  1. Birmingham, Alabama
  2. Mobile, Alabama
  3. Atlanta, Georgia
  4. Augusta, Georgia
  5. Shreveport, Louisiana
  6. Albany, New York
  7. Oklahoma City, Oklahoma
  8. Simpsonville, South Carolina
  9. Germantown, Tennessee
  10. Carroltown, Texas
  11. Dallas, Texas
  12. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
Official Title  ICMJE A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension
Brief Summary The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.
Detailed Description The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Resistant Hypertension
Intervention  ICMJE
  • Drug: Placebo
    placebo tablet once daily for 12 weeks
  • Drug: TBC3711
    10 mg tablets once daily for 10 weeks
  • Drug: TBC3711
    50 mg tablet once daily for 10 weeks
  • Drug: TBC3711
    100 mg tablet once daily for 10 weeks
  • Drug: TBC3711
    200 mg tablet once daily for 10 weeks
Study Arms  ICMJE
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
  • Experimental: ARM 1
    Intervention: Drug: TBC3711
  • Experimental: ARM 2
    Intervention: Drug: TBC3711
  • Experimental: ARM 3
    Intervention: Drug: TBC3711
  • Experimental: ARM 4
    Intervention: Drug: TBC3711
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 7, 2013)
60
Original Enrollment  ICMJE
 (submitted: January 4, 2006)
150
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of resistant hypertension.
  • A stable anti-hypertensive drug regimen for at least 30 days.

Exclusion Criteria:

  • Sustained blood pressure greater than or equal to 180/120 mmHg.
  • Required use of thigh cuff for blood pressure readings.
  • Uncontrolled diabetes mellitus.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00272961
Other Study ID Numbers  ICMJE B1341001
GRH01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP