check_circleStudy Completed

Hypertension

Effects of Adalat LA and Coracten on drug levels, blood pressure, and heart rate in fed patients with hypertension

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 75 Years

Trial summary

Enrollment Goal
43
Trial Dates
December 2003 - August 2004
Phase
Phase 4
Could I Receive a placebo
No
Products
Adalat GITS (Nifedipine, BAYA1040)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cambridge, CB2 2XY, United Kingdom
Withdrawn
United Kingdom

Primary Outcome

  • Maximum change in plasma norepinephrine in fed state dose administration to within 6 hours after the first dose
    date_rangeTime Frame:
    Up to 6 hours after first dose
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Single dose: change in epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions
    date_rangeTime Frame:
    After first dose
    enhanced_encryption
    Safety Issue:
    yes
  • Multi-dose: the change in norepinephrine, epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions
    date_rangeTime Frame:
    After 2 weeks dosing
    enhanced_encryption
    Safety Issue:
    yes
  • 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
    date_rangeTime Frame:
    Week 2 plus 1 day to week 4
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Effects of Adalat LA 30 mg and Coracten 30 mg on nifedipine plasma concentration , plasma catecholamines, blood pressure response and heart rate in fed mild to moderate hypertensive patients.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Basic Science
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2