NCT00672113

Brief Summary

This study compares the effect of Adalat LA to Coracten on drug levels as well as changes in blood pressure and heart rate in fed hypertensive subjects. Subjects are dosed with either Adalat or Coracten for first 2 weeks, followed by the other drug for 2 weeks, and then switched back to the original drug for one day. Blood samples, blood pressure, and heart rate are taken before and after each treatment period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

First QC Date

April 16, 2008

Last Update Submit

December 18, 2014

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Maximum change in plasma norepinephrine in fed state dose administration to within 6 hours after the first dose

    Up to 6 hours after first dose

Secondary Outcomes (3)

  • Single dose: change in epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions

    After first dose

  • Multi-dose: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions

    After 2 weeks dosing

  • The switch: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions after switching from Coracten to nifedipine and vice versa

    Week 2 plus 1 day to week 4

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Adalat (Nifedipine, BAYA1040)

Arm 2

ACTIVE COMPARATOR
Drug: Coracten

Interventions

Adalat (Nifedipine, BAYA1040)DRUG

Nifedipine GITS 30 mg followed by Coracten 30 mg then back to nifedipine GITS 30 mg

Arm 1
CoractenDRUG

Coracten 30 mg followed by nifedipine GITS 30 mg then back to Coracten 30 mg

Arm 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cambridge, Cambridgeshire, CB2 2XY, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2008

First Posted

May 6, 2008

Study Start

December 1, 2003

Study Completion

August 1, 2004

Last Updated

December 19, 2014

Record last verified: 2014-12

Locations

GB(1)