TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension

NCT00899977 | Terminated Phase 1

• 1 other identifier: TC-5214-23-CRD-002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Refractory Hypertension

Keywords

refractory hypertension; hypertension

Outcome Measures

Primary Outcomes (1)

• Mean difference between TC-5214 and placebo in change at 3 hours from baseline SBP

  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 Outcomes (1)

• Safety and tolerability of TC-5214 in patients with refractory hypertension and obtain preliminary dose-response estimates

  Days 1, 8, 15, 22 and 36

Study Arms (5)

Placebo

PLACEBO COMPARATOR

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

1 mg TC-5214

EXPERIMENTAL

Subjects may receive a single, oral capsule of 1 mg TC-5214 in one of 4 crossover periods.

Drug: TC-5214

2 mg TC-5214

EXPERIMENTAL

Subjects may receive a single, oral capsule of 2 mg TC-5214 in one of 4 crossover periods.

Drug: TC-5214

4 mg TC-5214

EXPERIMENTAL

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

8 mg TC-5214

EXPERIMENTAL

Subjects may receive a single, oral capsule of 8 mg TC-5214 in one of 4 crossover periods.

Drug: TC-5214

Interventions

Placebo DRUG

Matching placebo

Placebo

TC-5214 DRUG

1 mg TC-5214; 2 mg TC-5214; 4 mg TC-5214; 8 mg TC-5214

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (1)

Piedmont Medical Research

Winston-Salem, North Carolina, 27101, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

US (1)