Clinical trial NCT00272961: A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
Official title: A Phase 2 Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Ranging Study Of TBC3711 In Subjects With Resistant Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Resistant Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Maximum Blood Pressure (BP) Increase
timeFrame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
measure: Weighted Mean (Area Under Effect Curve [AUEC]) Blood Pressure Change
timeFrame: Baseline (Pre-Dose on Day 1 of Week 2) up to Week 12
Secondary outcomes:
measure: Sitting Systolic Blood Pressure (SBP)
timeFrame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
measure: Standing Systolic Blood Pressure (SBP)
timeFrame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
measure: Sitting Diastolic Blood Pressure (DBP)
timeFrame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
measure: Standing Diastolic Blood Pressure (DBP)
timeFrame: Pre-Dose and 2 hour Post-Dose on Baseline (Day 1 of Placebo Run-In Phase), Week 1, 2, 3, 4, 6, 8, 10
measure: Change From Standing to Sitting Systolic Blood Pressure (SBP) at Week 10
timeFrame: Pre-Dose and 2 hours Post-Dose on Week 10
measure: Change From Standing to Sitting Diastolic Blood Pressure (DBP) at Week 10
timeFrame: Pre-Dose and 2 hours Post-Dose on Week 10
measure: Change From Pre-Dose to Post-Dose in Systolic Blood Pressure (SBP) at Week 10
timeFrame: Pre-Dose and 2 hours Post-Dose on Week 10
measure: Change From Pre-Dose to Post-Dose in Diastolic Blood Pressure (DBP) at Week 10
timeFrame: Pre-Dose and 2 hours Post-Dose on Week 10
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Simpsonville
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Germantown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Carroltown
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: