A Randomized, Double-blinded, Placebo-controlled, Dose-ranging Study of Cardene® I.V. in Pediatric Subjects With Hypertension

NCT00528827 | Withdrawn Phase 2 DMC

• 1 other identifier: Cardene® I.V. 1406
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

To define the relationship between Cardene I.V. dose, serum concentrations, and blood pressure reduction in pediatric subjects with hypertension.

Conditions

Hypertension

Keywords

Hypertension, High Blood Pressure, Pediatric Hypertension, High blood pressure in children

Outcome Measures

Primary Outcomes (1)

• Mean percent change in SBP (Systolic Blood Pressure) from baseline during the 30-minute Randomized, Placebo-controlled Infusion Phase for each dose level of Cardene I.V. compared to placebo.

  30 minutes

Secondary Outcomes (1)

• 1) Mean percent change in SBP and DBP between various phases of dosing. 2) Proportion of subjects requiring additional antihypertensive medications during the treatment period. 3) Mean effective dose of Cardene I.V.

  72

Study Arms (4)

1

PLACEBO COMPARATOR

Drug: Cardene® I.V.

2

EXPERIMENTAL

5 mcg

Drug: Cardene® I.V.

3

EXPERIMENTAL

2.5

Drug: Cardene® I.V.

4

EXPERIMENTAL

0.5

Drug: Cardene® I.V.

Interventions

Cardene® I.V. DRUG

* 5 mcg/kg/min Cardene I.V. * 2.5 mcg/kg/min Cardene I.V. * 0.5 mcg/kg/min Cardene I.V.

1; 2; 3; 4

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Evidence of Stage 1 or Stage 2 systolic hypertension at the time of screening.
• Male or female subjects, ages ≥2 to ≤16 years.
• Females who meet either of the following criteria:
• Non-childbearing potential , as documented by:
• a medical history of non-menstruation or
• surgical sterility from oophorectomy and/or hysterectomy. \* A history of tubal ligation or evidence of a sterile sexual partner is insufficient evidence of non-childbearing potential.
• Childbearing potential: provide a negative urine pregnancy test within 24 hours of administration of study drug and agree to utilize effective contraception or remain abstinent during the entire treatment and follow-up periods of the study.
• Signed informed consent provided by an authorized subject representative and assent from subject, if feasible (based on local Institutional Review Board (IRB)/ethics panel requirements).

You may not qualify if:

• Subjects with seizures, altered state of consciousness, chest pain, facial palsy or intracranial hemorrhage at the time of screening.
• Receiving antihypertensive medication within a duration specified prior to screening.
• Treatment with cimetidine within 10 hours prior to dosing with study drug.
• Any known or suspected allergy to nicardipine hydrochloride.
• A calculated Glomerular Filtration Rate (GFR) under 30 mL/min/ 1.73 m2 as calculated using the Schwartz formula and the associated K values.
• Known history of severe aortic stenosis.
• Known history of severe left ventricular dysfunction.
• Known history of severely impaired hepatic function with portal hypertension.
• Liver function test (AST or ALT) results greater than or equal to twice the upper limit of normal.
• Receiving maintenance hemodialysis at screening or anticipated to require hemodialysis within 12 hours following initiation of treatment with study drug.
• Receiving a blood transfusion at screening or anticipated to require blood transfusions within 12 hours following initiation of treatment with study drug.
• Lack of appropriate intravenous (I.V.) access.
• Inability to tolerate a large-volume I.V. infusion.
• Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.
• Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.

Sponsors & Collaborators

• Facet Biotech: lead

Study Sites (2)

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Miami, Florida, 33145, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2007
• First Posted: September 12, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (2)