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TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension

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ClinicalTrials.gov Identifier: NCT00899977
Recruitment Status : Terminated (Business reasons)
First Posted : May 12, 2009
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):
Targacept Inc.

Study Description
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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 study medication in clinic.

Condition or disease Intervention/treatment Phase
Refractory Hypertension Drug: Placebo Drug: TC-5214 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: Placebo
Matching placebo
Experimental: 1 mg TC-5214
Subjects may receive a single, oral capsule of 1 mg TC-5214 in one of 4 crossover periods.
 Drug: TC-5214
Experimental: 2 mg TC-5214
Subjects may receive a single, oral capsule of 2 mg TC-5214 in one of 4 crossover periods.
 Drug: TC-5214
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.
 Drug: TC-5214
Experimental: 8 mg TC-5214
Subjects may receive a single, oral capsule of 8 mg TC-5214 in one of 4 crossover periods.
 Drug: TC-5214


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Outpatient with stable housing.
  4. Subjects must be able to stay in the clinic for 8 hrs on Day 1, Day 8, Day 15, Day 22, and Day 36.
  5. Able to give and to sign informed consent.

Exclusion Criteria:

  1. Any unstable medical condition other than hypertension;
  2. Stage 3 hypertension (SBP > 180mmHg and/or DBP > 110mmHg);
  3. Heart rate > 100 beats per minute;
  4. WOCBP who is pregnant or who is planning to become pregnant during the study;
  5. History within past year of alcohol or illicit drug abuse;
  6. Unable to comply with study procedures in opinion of investigator;
  7. Concomitant medications for any medical condition that is uncontrolled for more than 2 weeks prior to study entry;
  8. Current use of alpha-adrenergic blocker, hydralazine, clonidine, guanethidine, guanadrel, or rauwolfia alkaloids;
  9. History of myocardial infarction or angina pectoris;
  10. Current seizure disorder;
  11. Renal insufficiency as defined by a serum creatinine > 2.0;
  12. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency;
  13. History of or concurrent ileus, glaucoma, or urinary retention;
  14. Inability of subject to understand and sign the ICF;
  15. Known systemic infection (HBV, HCV, HIV, TB);
  16. Current use of smoking cessation therapy within 4 weeks of screening;
  17. Use of herbal supplements;
  18. Clinically significant finding on physical exam;
  19. Clinically significant laboratory or ECG abnormality, including QTcF > 460 msec;
  20. Participation in another clinical trial in last month;
  21. Body Mass Index (BMI) > 35.
  22. Body weight < 100 pounds.
  23. Site staff or family member of study site staff.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899977


Locations
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United States, North Carolina
Piedmont Medical Research
Winston-Salem, North Carolina, United States, 27101
Sponsors and Collaborators
Targacept Inc.
More Information
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Responsible Party: Targacept Inc.
ClinicalTrials.gov Identifier: NCT00899977    
Other Study ID Numbers: TC-5214-23-CRD-002
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013
Keywords provided by Targacept Inc.:
refractory hypertension
hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases