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HypertensionPhase 4NCT00672113

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

A Phase 4 study testing Adalat (Nifedipine, BAYA1040) and Coracten in people with Hypertension, run by Bayer at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Adalat (Nifedipine, BAYA1040) and Coracten
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2003to Aug 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Study site

    Cambridge, Cambridgeshire, CB2 2XY

Other trials in United Kingdom

About this study

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.

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.

Conditions
Hypertension
Being tested
Adalat (Nifedipine, BAYA1040), Coracten
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adalat (Nifedipine, BAYA1040)Drug

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

  • CoractenDrug

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

Study groups in NCT00672113
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Adalat (Nifedipine, BAYA1040)
Arm 2Active comparatorNot described
Receives: Drug: Coracten

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 6 hours after first dose

Secondary outcomes (3)
  1. Single dose: change in epinephrine, SBP, DBP, HR, and plasma nifedipine concentration time profile including Cmax and tmax under fed conditions

    Measured: After first dose

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

    Measured: After 2 weeks dosing

  3. 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

    Measured: Week 2 plus 1 day to week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2008 (estimated)
  2. Study startDec 2003
  3. Study completionAug 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672113
Sponsor's protocol ID
100128
Status last verified
Dec 2014
First submitted
16 Apr 2008
Last updated
19 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalat (Nifedipine, BAYA1040) and Coracten in people with Hypertension, run by Bayer at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.

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