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Study 26 of 205 for search of: | "Tocolytic Agents" |
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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00672113 |
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 IV |
Study Type: | Interventional |
Study Design: | Active Control, Basic Science, Crossover Assignment, Open Label, Randomized, Safety 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. |
Enrollment: | 40 |
Study Start Date: | December 2003 |
Study Completion Date: | August 2004 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Adalat (Nifedipine, BAYA1040)
Nifedipine GITS 30 mg followed by Coracten 30 mg then back to nifedipine GITS 30 mg
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Arm 2: Active Comparator |
Drug: Coracten
Coracten 30 mg followed by nifedipine GITS 30 mg then back to Coracten 30 mg
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with previously known clinically significant abnormalities of laboratory tests that might suggest further investigation.
m) Subjects with a resting heart rate < 50 bpm or > 100 bpm.
Responsible Party: | Medical Affairs Therapeutic Area Head ( Bayer Inc., Canada ) |
Study ID Numbers: | 100128 |
Study First Received: | April 16, 2008 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00672113 History of Changes |
Health Authority: | Canada: Health Canada; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Calcium, Dietary Vasodilator Agents Vascular Diseases Calcium Channel Blockers |
Cardiovascular Agents Nifedipine Hypertension |
Tocolytic Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vascular Diseases Calcium Channel Blockers Cardiovascular Agents |
Reproductive Control Agents Nifedipine Pharmacologic Actions Membrane Transport Modulators Therapeutic Uses Cardiovascular Diseases Hypertension |