Effects of Adalat LA and Coracten on Drug Levels, Blood Pressure, and Heart Rate in Fed Patients With Hypertension

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00672113
First received: April 16, 2008
Last updated: April 28, 2010
Last verified: April 2010
  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.


Condition Intervention Phase
Hypertension
Drug: Adalat (Nifedipine, BAYA1040)
Drug: Coracten
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Maximum change in plasma norepinephrine in fed state dose administration to within 6 hours after the first dose [ Time Frame: Up to 6 hours after first dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Single dose: change in epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions [ Time Frame: After first dose ] [ Designated as 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 [ Time Frame: After 2 weeks dosing ] [ Designated as 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 [ Time Frame: Week 2 plus 1 day to week 4 ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: December 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Adalat (Nifedipine, BAYA1040)
Nifedipine GITS 30 mg followed by Coracten 30 mg then back to nifedipine GITS 30 mg
Active Comparator: Arm 2 Drug: Coracten
Coracten 30 mg followed by nifedipine GITS 30 mg then back to Coracten 30 mg

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672113

Locations
United Kingdom
Cambridge, Cambridgeshire, United Kingdom, CB2 2XY
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Affairs Therapeutic Area Head, Bayer Inc., Canada
ClinicalTrials.gov Identifier: NCT00672113     History of Changes
Other Study ID Numbers: 100128
Study First Received: April 16, 2008
Last Updated: April 28, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Nifedipine
Calcium Channel Blockers
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Tocolytic Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 23, 2014