check_circleStudy Completed

Hypertension

Bayer Identifier:

100128

ClinicalTrials.gov Identifier:

NCT00672113

EudraCT Number:

Not Available

EU CT Number:

Not Available
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
  • - Mild to moderate hypertension (sitting DBP > 95 - <114 mmHg and/or SBP > 140 - < 160 mmHg) currently untreated. or- Previously diagnosed mild to moderate hypertension (DBP 95-114 mmHg and/or SBP 140 - 160 mmHg) well controlled on current treatment but experiencing adverse events who can be safely switched to the study treatments. or- Previously diagnosed mild to moderate hypertension (DBP 95-114 mmHg and/or SBP 140 - 160 mmHg), well controlled on current treatment, without adverse events, and willing to participate in the study.
  • - Females who are pregnant, nursing or of childbearing age, unless sterilised. Subjects receiving any form of contraception are not eligible.- Subjects with a medical history of cardiac disease within 6 months (e.g. myocarditis or pericarditis, aortic stenosis, myocardial infarction, unstable angina pectoris or severe angina pectoris). - Subjects with history or evidence of congestive heart failure- Subjects with evidence of clinically important arrhythmia or conduction disturbances requiring treatment.- Subjects with severe liver disease (liver enzymes twice the upper limit of "normal") or other gastrointestinal (GI) tract diseases including inflammatory bowel disease or Crohns disease- Subjects with lactose intolerance.- Subjects with renal diseases (creatinine > 1.5 mg/dL), which could alter the absorption, metabolism or excretion of the study drugs.- Subjects with Type I diabetes. - Subjects taking drugs which may interfere with the metabolism of nifedipine (cimetidine, ranitidine, quinidine, digoxin, rifampicin, diltiazem, cisapride, quinupristin/dalfopristin, cyclosporin, phenytoin or other antiepileptic drugs,).- Subjects suffering from secondary or malignant hypertension.- Subjects with any known contraindication (e.g. hypersensitivity) to nifedipine or other calcium channel blockers of the dihydropyridine class.- Subjects with previously known clinically significant abnormalities of laboratory tests that might suggest further investigation.- Subjects with a resting heart rate < 50 bpm or > 100 bpm.- Subjects with a history of drug and/or alcohol abuse.- Subjects unwilling to comply with the protocol.- Subjects who have participated in another clinical trial within the last month.- Subjects with neurologic or psychiatric illness requiring medication (e.g. tricyclic antidepressants, MAO inhibitors).- Subjects with clinical evidence of ongoing or recent (within the last year) stroke or transient ischemic attacks.- Subjects with pre-existing severe gastrointestinal or oesophageal constriction or narrowing.

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

Additional Information

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