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Trial record 6 of 19 for:    TC-5214

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.

Tracking Information
First Submitted Date  ICMJE May 8, 2009
First Posted Date  ICMJE May 12, 2009
Last Update Posted Date September 13, 2013
Study Start Date  ICMJE May 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2009)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
Mean difference between TC-5214 and placebo in change at 3 hours from baseline DBP [ 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. ]
Change History Complete list of historical versions of study NCT00899977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Refractory Hypertension
Intervention  ICMJE
  • Drug: Placebo
    Matching placebo
  • Drug: TC-5214
Study Arms
  • 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.
    Intervention: Drug: Placebo
  • Experimental: 1 mg TC-5214
    Subjects may receive a single, oral capsule of 1 mg TC-5214 in one of 4 crossover periods.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: TC-5214
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 5, 2009)
1
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2009)
12
Actual Study Completion Date December 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00899977
Other Study ID Numbers  ICMJE TC-5214-23-CRD-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Targacept Inc.
Study Sponsor  ICMJE Targacept Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Targacept Inc.
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP