- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00899977
TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
September 3, 2013 updated by: Targacept Inc.
A Double-blind, Randomized, Placebo-controlled, Sequential Group Pilot Study to Assess Safety, Tolerability, and Effectiveness of TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
A pilot study of subjects with refractory hypertension (on 3 concomitant agents with SBP > 140 mmHg and a DBP > 90 mmHg) randomized in a double-blind fashion to receive 4 single escalating doses of study medication in clinic.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
12 subjects with refractory hypertension will be randomized in a double-blind fashion to receive single escalating doses of study medication in-clinic: on Day 1 (1mg), Day 8 (2mg), Day 15 (4mg) and Day 22 (8mg).
On each of these 4 days, 10 subjects will receive TC-5214, and 2 subjects will receive placebo.
Placebo treatments will be pooled across the 4 days of single-dose to produce an equivalent reference cohort (n = 8) for each treatment dose (n=10).
Following the single-dose administration of 8mg in the clinic on Day 22, subjects will continue with two weeks (Days 23 - 35) of outpatient self-administration of TC-5214 (4mg BID; n = 6), or matching placebo (BID; n = 6).
On Day 36, subjects will return for a final in-clinic dose of either TC-5214 (4mg, n = 6) or placebo (n = 6).
There will be a 1-week follow-up period at the end of the treatment period.
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27101
- Piedmont Medical Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Refractory hypertension, defined as a SBP of >140mmHg and a DBP > 90mmHg, on stable doses of at least 3 concomitant antihypertensive treatment (which must include a diuretic and an ACEI, ARB or RA) for 8 weeks prior to Screening. All approved antihypertensive treatments are allowed except for alpha-adrenergic blockers, hydralazine, clonidine, guanethidine, guanadrel, and rauwolfia alkaloids.
- Stable hypertension, as defined by: a. mean SBP on Day -7 that is within 20mmHg of the mean SBP on Day 1, with both mean SBPs > 140mmHg; and b. mean DBP on Day -7 that is within 10mm of the mean DBP on Day 1, with both mean DBPs > 90mmHg.
- Outpatient with stable housing.
- Subjects must be able to stay in the clinic for 8 hrs on Day 1, Day 8, Day 15, Day 22, and Day 36.
- Able to give and to sign informed consent.
Exclusion Criteria:
- Any unstable medical condition other than hypertension;
- Stage 3 hypertension (SBP > 180mmHg and/or DBP > 110mmHg);
- Heart rate > 100 beats per minute;
- WOCBP who is pregnant or who is planning to become pregnant during the study;
- History within past year of alcohol or illicit drug abuse;
- Unable to comply with study procedures in opinion of investigator;
- Concomitant medications for any medical condition that is uncontrolled for more than 2 weeks prior to study entry;
- Current use of alpha-adrenergic blocker, hydralazine, clonidine, guanethidine, guanadrel, or rauwolfia alkaloids;
- History of myocardial infarction or angina pectoris;
- Current seizure disorder;
- Renal insufficiency as defined by a serum creatinine > 2.0;
- Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency;
- History of or concurrent ileus, glaucoma, or urinary retention;
- Inability of subject to understand and sign the ICF;
- Known systemic infection (HBV, HCV, HIV, TB);
- Current use of smoking cessation therapy within 4 weeks of screening;
- Use of herbal supplements;
- Clinically significant finding on physical exam;
- Clinically significant laboratory or ECG abnormality, including QTcF > 460 msec;
- Participation in another clinical trial in last month;
- Body Mass Index (BMI) > 35.
- Body weight < 100 pounds.
- Site staff or family member of study site staff.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Subjects may receive a single, oral dose of placebo (capsule) in one of 4 crossover periods.
Also, subjects may receive placebo orally, twice daily for 14 days in the last phase of the study.
|
Matching placebo
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Experimental: 1 mg TC-5214
Subjects may receive a single, oral capsule of 1 mg TC-5214 in one of 4 crossover periods.
|
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Experimental: 2 mg TC-5214
Subjects may receive a single, oral capsule of 2 mg TC-5214 in one of 4 crossover periods.
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|
Experimental: 4 mg TC-5214
Subjects may receive a single, oral capsule of 4 mg TC-5214 in one of 4 crossover periods.
Also, subjects may receive 4 mg TC-5214 orally, twice daily for 14 days in the last phase of the study.
|
|
Experimental: 8 mg TC-5214
Subjects may receive a single, oral capsule of 8 mg TC-5214 in one of 4 crossover periods.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean difference between TC-5214 and placebo in change at 3 hours from baseline SBP
Time Frame: Following dosing, 3 manual seated BP measurements and orthostatic BP measurements will be obtained in an identical fashion, at 30 minutes post-dose and at 1, 2, 3, 4, 5, 6, 7, and 8 hrs post-dose.
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Following dosing, 3 manual seated BP measurements and orthostatic BP measurements will be obtained in an identical fashion, at 30 minutes post-dose and at 1, 2, 3, 4, 5, 6, 7, and 8 hrs post-dose.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability of TC-5214 in patients with refractory hypertension and obtain preliminary dose-response estimates
Time Frame: Days 1, 8, 15, 22 and 36
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Days 1, 8, 15, 22 and 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
May 8, 2009
First Submitted That Met QC Criteria
May 11, 2009
First Posted (Estimate)
May 12, 2009
Study Record Updates
Last Update Posted (Estimate)
September 13, 2013
Last Update Submitted That Met QC Criteria
September 3, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC-5214-23-CRD-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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