Status:
TERMINATED
TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
Lead Sponsor:
Targacept Inc.
Conditions:
Refractory Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
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 Da...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00899977
Start Date
May 1 2009
End Date
December 1 2009
Last Update
September 13 2013
Active Locations (1)
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1
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27101