Study Stopped
See termination reason in detailed description.
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension
2 other identifiers
interventional
60
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2006
12 active sites
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
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
March 5, 2013
CompletedMarch 5, 2013
January 1, 2013
2.6 years
January 4, 2006
January 28, 2013
January 28, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum Blood Pressure (BP) Increase
BP is the pressure of the blood within the arteries. It is produced primarily by the contraction of the heart muscle. BP measurement is recorded by 2 numbers: systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). Maximum increase was calculated by subtracting baseline value from each post-dose measurement and selecting maximum of these values.
Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
AUEC was calculated as the positive area under the change from baseline curve for sitting and standing SBP and DBP to Week 12, estimated by the linear trapezoidal rule corrected for the pre-dose baseline value. In the event that post-dose values returned below baseline at or before Week 12, then AUEC was calculated by setting the negative values to zero and taking only the positive area into account.
Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Secondary Outcomes (8)
Sitting Systolic Blood Pressure (SBP)
Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Standing Systolic Blood Pressure (SBP)
Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Sitting Diastolic Blood Pressure (DBP)
Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Standing Diastolic Blood Pressure (DBP)
Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
Pre-Dose and 2 hours Post-Dose on Week 10
- +3 more secondary outcomes
Study Arms (5)
placebo
PLACEBO COMPARATORARM 1
EXPERIMENTALARM 2
EXPERIMENTALARM 3
EXPERIMENTALARM 4
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of resistant hypertension.
- A stable anti-hypertensive drug regimen for at least 30 days.
You may not qualify if:
- Sustained blood pressure greater than or equal to 180/120 mmHg.
- Required use of thigh cuff for blood pressure readings.
- Uncontrolled diabetes mellitus.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (12)
Pfizer Investigational Site
Birmingham, Alabama, 35294-2041, United States
Pfizer Investigational Site
Mobile, Alabama, 36608, United States
Pfizer Investigational Site
Atlanta, Georgia, 30309, United States
Pfizer Investigational Site
Augusta, Georgia, 30904, United States
Pfizer Investigational Site
Shreveport, Louisiana, 71101, United States
Pfizer Investigational Site
Albany, New York, 12206, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73132-4904, United States
Pfizer Investigational Site
Simpsonville, South Carolina, 29681, United States
Pfizer Investigational Site
Germantown, Tennessee, 38138, United States
Pfizer Investigational Site
Carroltown, Texas, 75006, United States
Pfizer Investigational Site
Dallas, Texas, 75235, United States
Pfizer Investigational Site
Seattle, Washington, 98133, United States
Related Links
MeSH Terms
Interventions
Limitations and Caveats
Results for 'change from standing to sitting SBP and DBP' and 'change from pre-dose to post-dose SBP and DBP' are reported only at Week 10 as per changes in planned analysis because of early termination of the study and clinical development program.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
January 1, 2006
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
March 5, 2013
Results First Posted
March 5, 2013
Record last verified: 2013-01