MedDataX Logo

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

NCT ID: NCT00272961

Last Updated: 2013-03-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Dose Finding Study Of PF-00489791 In Patients With Mild To Moderate High Blood Pressure

NCT00422461

Hypertension
COMPLETED PHASE2

An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

NCT05562934

Resistant Hypertension
COMPLETED PHASE2

Optimum Treatment for Drug-Resistant Hypertension

NCT02369081

Hypertension, Resistant to Conventional Therapy
UNKNOWN PHASE4

An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

NCT01281306

Systolic Hypertension
COMPLETED PHASE2

Safety and Efficacy Study of LHW090 in Resistant Hypertension Patients

NCT02515331

Patients, Resistant Hypertension
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Resistant Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo tablet once daily for 12 weeks

ARM 1

Group Type EXPERIMENTAL

TBC3711

Intervention Type DRUG

10 mg tablets once daily for 10 weeks

ARM 2

Group Type EXPERIMENTAL

TBC3711

Intervention Type DRUG

50 mg tablet once daily for 10 weeks

ARM 3

Group Type EXPERIMENTAL

TBC3711

Intervention Type DRUG

100 mg tablet once daily for 10 weeks

ARM 4

Group Type EXPERIMENTAL

TBC3711

Intervention Type DRUG

200 mg tablet once daily for 10 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

placebo tablet once daily for 12 weeks

Intervention Type DRUG

TBC3711

10 mg tablets once daily for 10 weeks

Intervention Type DRUG

TBC3711

50 mg tablet once daily for 10 weeks

Intervention Type DRUG

TBC3711

100 mg tablet once daily for 10 weeks

Intervention Type DRUG

TBC3711

200 mg tablet once daily for 10 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Mobile, Alabama, United States

Site Status

Pfizer Investigational Site

Atlanta, Georgia, United States

Site Status

Pfizer Investigational Site

Augusta, Georgia, United States

Site Status

Pfizer Investigational Site

Shreveport, Louisiana, United States

Site Status

Pfizer Investigational Site

Albany, New York, United States

Site Status

Pfizer Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

Pfizer Investigational Site

Simpsonville, South Carolina, United States

Site Status

Pfizer Investigational Site

Germantown, Tennessee, United States

Site Status

Pfizer Investigational Site

Carroltown, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1341001&StudyName=A%20study%20of%20different%20doses%20of%20TBC3711%20in%20patients%20with%20uncontolled%20high%20blood%20pressure%20already%20taking%20medications%20for%20high%20blood%20press

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GRH01

Identifier Type: -

Identifier Source: secondary_id

B1341001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study of CIN-107 in Adults With Treatment-Resistant Hypertension (rHTN)
NCT04519658 COMPLETED PHASE2
Effectiveness of a Valsartan Based vs an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy
NCT00351130 COMPLETED PHASE4
Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension
NCT00362115 COMPLETED PHASE2
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood Pressure in Participants With Resistant Hypertension
NCT06168409 COMPLETED PHASE3
Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
NCT00931710 COMPLETED PHASE4
A Study Of Valsartan Used To Treat Hypertension For Up To 13 Months In Hypertensive Children Ages 6 - 16 Years Of Age
NCT00171041 COMPLETED PHASE3
A Research Study to Show the Effect of Aprocitentan in the Treatment of Difficult to Control (Resistant) High Blood Pressure (Hypertension) and Find Out More About Its Safety
NCT03541174 COMPLETED PHASE3
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
NCT00549770 COMPLETED PHASE2
A Study Of Valsartan Used To Treat Hypertension For Up To 56 Weeks In Children Ages 1 - 5 Years Who Have Hypertension
NCT00171028 COMPLETED PHASE3
Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension
NCT00171054 COMPLETED PHASE4
Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study
NCT00706134 COMPLETED PHASE3
Study to Compare the Effect of Valsartan vs Atenolol on Pro-thrombotic State in Hypertensive Patients.
NCT00171756 COMPLETED PHASE4
Comparison of Two Treatment Strategies in Hypertensive Patients
NCT00171444 COMPLETED PHASE4
Efficacy and Safety of Valsartan Plus Hydrochlorothiazide in Fixed Dose Combination in Hypertensive Patients Not Controlled by the Free Combination of an Angiotensin Receptor Blocker Plus Hydrochlorothiazide
NCT00360178 COMPLETED PHASE3
Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
NCT00523744 COMPLETED PHASE3
Antihypertensive Efficacy of Fixed Combination Drug
NCT01211314 TERMINATED PHASE4
Long-term Study of CS-3150 as Monotherapy or in Combination With Other Antihypertensive Drug in Japanese Patients With Essential Hypertension
NCT02722265 COMPLETED PHASE3
Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension
NCT01508026 COMPLETED PHASE3
A Study to Evaluate CIN-107 for the Treatment of Patients With Uncontrolled Hypertension and Chronic Kidney Disease
NCT05432167 COMPLETED PHASE2
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)
NCT00246584 COMPLETED PHASE2
A Study to Evaluate the Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled on Monotherapy
NCT00327145 COMPLETED PHASE3
Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension
NCT05001945 COMPLETED PHASE2
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure
NCT00435162 COMPLETED PHASE3
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
NCT00277472 COMPLETED PHASE4
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
NCT00765947 COMPLETED PHASE4