A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00272961
First received: January 4, 2006
Last updated: January 28, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Resistant Hypertension |
Drug: Placebo Drug: TBC3711 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Maximum Blood Pressure (BP) Increase [ Time Frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 ] [ Designated as safety issue: Yes ]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.
- Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change [ Time Frame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12 ] [ Designated as safety issue: Yes ]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.
Secondary Outcome Measures:
- Sitting Systolic Blood Pressure (SBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80 percent [%] of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.
- Standing Systolic Blood Pressure (SBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.
- Sitting Diastolic Blood Pressure (DBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements. The same arm was used throughout the study.
- Standing Diastolic Blood Pressure (DBP) [ Time Frame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10 ] [ Designated as safety issue: Yes ]DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) after participant stood for 2 minutes. The same arm was used throughout the study.
- Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
- Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
- Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]SBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
- Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10 [ Time Frame: Pre-Dose and 2 hours Post-Dose on Week 10 ] [ Designated as safety issue: Yes ]DBP is the BP (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed and average was calculated at each time point in participant's non-dominant arm using appropriate-sized cuff (cuff bladder encircling at least 80% of the arm). The same arm was used throughout the study.
| Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: Placebo
placebo tablet once daily for 12 weeks
|
| Experimental: ARM 1 |
Drug: TBC3711
10 mg tablets once daily for 10 weeks
|
| Experimental: ARM 2 |
Drug: TBC3711
50 mg tablet once daily for 10 weeks
|
| Experimental: ARM 3 |
Drug: TBC3711
100 mg tablet once daily for 10 weeks
|
| Experimental: ARM 4 |
Drug: TBC3711
200 mg tablet once daily for 10 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272961
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294-2041 | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| Pfizer Investigational Site | |
| Augusta, Georgia, United States, 30904 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71101 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Albany, New York, United States, 12206 | |
| United States, Oklahoma | |
| Pfizer Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73132-4904 | |
| United States, South Carolina | |
| Pfizer Investigational Site | |
| Simpsonville, South Carolina, United States, 29681 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Germantown, Tennessee, United States, 38138 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Carroltown, Texas, United States, 75006 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75235 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Seattle, Washington, United States, 98133 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00272961 History of Changes |
| Other Study ID Numbers: | B1341001, GRH01 |
| Study First Received: | January 4, 2006 |
| Results First Received: | January 28, 2013 |
| Last Updated: | January 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013