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Merck nicox news: NCT00871871
Auj. à 00:35
Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis
This study has been completed.
First Received: March 27, 2009 Last Updated: May 6, 2010 History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00871871
Purpose
This study will measure and compare changes in insulin production and sensitivity using the hyperglycemic clamp technique in obese patients with impaired glucose tolerance and hypertension treated with placebo, isosorbide mononitrate (ISMN) or hydrochlorothiazide (HCTZ).
Condition Intervention Phase
Hypertension
Drug: Hydrochlorothiazide (HCTZ)
Drug: Comparator: Placebo to HCTZ
Drug: Comparator: Isosorbide mononitrate (ISMN)
Drug: Comparator: Placebo to ISMN
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 2-Part Study to Evaluate the Multiple Dose Effects of Hydrochlorothiazide and Isosorbide Mononitrate on Glucose Homeostasis in Obese Patients With Hypertension
Resource links provided by NLM:
MedlinePlus related topics: Diabetes Medicines High Blood Pressure Obesity
Drug Information available for: Hydrochlorothiazide Isosorbide-5-mononitrate Isosorbide dinitrate Isosorbide
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
•Part I: Decrease in insulin secretion at steady-state compared to placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
•Part II: Increase in the ratio of whole body glucose disposal to plasma insulin at steady-state [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
•Part I: Decrease in the ratio of whole body glucose disposal to plasma insulin at steady state [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: March 2009
Study Completion Date: March 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Part I, Arm 1: Experimental
Placebo in Period 1 followed by HCTZ in Period 2 Drug: Hydrochlorothiazide (HCTZ)
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Drug: Comparator: Placebo to HCTZ
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Part I, Arm 2: Experimental
HCTZ in Period 1, followed by placebo in Period 2 Drug: Hydrochlorothiazide (HCTZ)
HCTZ 50 mg (two 25 mg capsules) once daily for 4 weeks per treatment period.
Drug: Comparator: Placebo to HCTZ
Placebo to HCTZ two 0 mg capsules once daily for 4 weeks per treatment period
Part II, Arm 1: Experimental
Placebo in Period 1, followed by ISMN in Period 2 Drug: Comparator: Isosorbide mononitrate (ISMN)
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Drug: Comparator: Placebo to ISMN
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
Part II, Arm 2: Experimental
ISMN in Period 1, followed by placebo in Period 2 Drug: Comparator: Isosorbide mononitrate (ISMN)
ISMN 60 mg extended release capsule once daily for 4 weeks per treatment period
Drug: Comparator: Placebo to ISMN
Placebo to ISMN 0 mg capsule once daily for 4 weeks per treatment period
Eligibility
Ages Eligible for Study: 35 Years to 75 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Female patients must be post-menopausal
•Patient has a BMI of at least 29 kg/m^2
•Patient's weight has been stable over the past 3 months
•Patient has never been treated for hypertension or is diagnosed with hypertension taking up to 2 anti-hypertensive medications
•Patient is willing to stop hypertension treatment for 14 days prior to randomization and throughout the study
•Patient does not have a history of diabetes
•Patient is in good health with the exception of hypertension
•Patient has no history of abnormal heart rhythms
•Part I only: Patient is willing to comply with high potassium/low sodium diet for the duration of the study
•Patient is willing to avoid strenuous physical activity during the study
•Patient is a nonsmoker and/or has not used nicotine for at least 3 months and agrees to refrain from use of tobacco-containing products throughout the study
•Patient agrees to refrain from consuming alcohol and caffeine during in-patient periods and to limit consumption at all other times during the study
•Patient agrees not to consume grapefruit, grapefruit products, and citrus, apple, and pineapple juices 2 weeks prior to administration of the first dose of study drug
Exclusion Criteria:
•Patient has a history of any illness that may make their participation in the study unsafe or confuse the study results
•Patient is taking spironolactone or eplerenone
•Patient cannot refrain from using any prescription or non-prescription drugs during the study
•Patient is on a weight loss program and is not in the maintenance phase
•Patient started a weight loss drug within 8 weeks of the first study visit
•Patient consumes excessive amounts of alcohol or caffeine
•Patient has had major surgery, donated or lost 1 unit of blood within 4 weeks of the first study visit
•Patient has a history of multiple and/or severe allergies to drugs or food
•Patient is dehydrated
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871871
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
More Information
No publications provided
Responsible Party: Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
ClinicalTrials.gov Identifier: NCT00871871 History of Changes
Other Study ID Numbers: 2009_567, 117
Study First Received: March 27, 2009
Last Updated: May 6, 2010
Health Authority: South Africa: Medicines Control Council
Additional relevant MeSH terms:
Antihypertensive Agents
Isosorbide
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Isosorbide-5-mononitrate
Diuretics, Osmotic
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Isosorbide Dinitrate
Cardiovascular Agents
Hydrochlorothiazide
Pharmacologic Actions
Nitric Oxide Donors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension
ClinicalTrials.gov processed this record on July 12, 2010
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Merck Nicox news: NCT00943852
Auj. à 00:32
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements
This study has been completed.
First Received: July 21, 2009 No Changes Posted
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00943852
Purpose
This study will qualify a functional model that can measure central blood pressure and vascular compliance effects through noninvasive means.
Condition Intervention Phase
Hypertension
Drug: losartan potassium
Drug: Comparator: isosorbide mononitrate (ISMN)
Drug: Comparator: losartan + ISMN
Drug: Comparator: Placebo
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Double-Blind, Randomized, Placebo-Controlled, 5-Period Crossover Study to Evaluate the Effects of a Single Dose of Losartan, a Single Dose of Isosorbide Mononitrate (ISMN), and Single Doses of Losartan + ISMN on Central Blood Pressure Measurements in Mildly Hypertensive Patients
Resource links provided by NLM:
MedlinePlus related topics: High Blood Pressure
Drug Information available for: Isosorbide-5-mononitrate Isosorbide dinitrate Losartan Losartan potassium Isosorbide
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
•Mean augmentation index% after single doses of losartan 100 mg plus ISMN 60 mg versus single dose of losartan 100 mg [ Time Frame: 10 hours postdose ] [ Designated as safety issue: No ]
•Mean augmentation index% after single doses of losartan 100 mg plus ISMN 60 mg versus single dose of placebo [ Time Frame: 10 hours postdose ] [ Designated as safety issue: No ]
Enrollment: 18
Study Start Date: August 2006
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
losartan 100 mg Drug: losartan potassium
Single dose losartan 100 mg in one of five treatment periods
2: Active Comparator
ISMN 60 mg Drug: Comparator: isosorbide mononitrate (ISMN)
Single dose ISMN 60 mg in one of five treatment periods
3: Active Comparator
losartan 100 mg + ISMN 15 mg Drug: Comparator: losartan + ISMN
Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods
4: Active Comparator
losartan 100 mg + ISMN 60 mg Drug: Comparator: losartan + ISMN
Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods
5: Placebo Comparator
Placebo Drug: Comparator: Placebo
Single dose placebo only in one of five treatment periods
Eligibility
Ages Eligible for Study: 45 Years to 70 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
•Patient is in good health with the exception of mild to moderate hypertension
•Patient is willing to comply with the study restrictions
•Patient does not smoke
Exclusion Criteria:
•Patient has a history of any illness that might confound the results of the study or make participation in the study unsafe
•Patient is taking a prescription medication that is contraindicated for use with COZAAR® or IMDUR®
•Patient has a condition for which there is a warning, contraindication, or precaution against the use of COZAAR® or IMDUR®
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943852
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
More Information
Additional Information:
MedWatch - FDA maintained medical product safety Information
PhRMA Clinical Study Results Database - web-based repository for clinical study results
Merck: Patient & Caregiver U.S. Product Web Site
No publications provided
Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
ClinicalTrials.gov Identifier: NCT00943852 History of Changes
Other Study ID Numbers: 2009_610, MK0954-317
Study First Received: July 21, 2009
Last Updated: July 21, 2009
Health Authority: United States: Food and Drug Administration
Additional relevant MeSH terms:
Antihypertensive Agents
Isosorbide
Vasodilator Agents
Losartan
Molecular Mechanisms of Pharmacological Action
Isosorbide-5-mononitrate
Diuretics, Osmotic
Diuretics
Physiological Effects of Drugs
Vascular Diseases
Isosorbide Dinitrate
Cardiovascular Agents
Pharmacologic Actions
Nitric Oxide Donors
Angiotensin II Type 1 Receptor Blockers
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension
ClinicalTrials.gov processed this record on July 12, 2010
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Merck nicox news:NCT01130168
Auj. à 00:23
The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Subjects and Patients With Hypertension
This study is not yet open for participant recruitment.
Verified by Merck, May 2010
First Received: May 19, 2010 Last Updated: May 26, 2010 History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT01130168
Purpose
This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of ISMN or Amlodipine in patients with hypertension.
Condition Intervention Phase
Hypertension
Drug: Placebo
Drug: Comparator: Amlodipine
Drug: Comparator: ISMN ER
Phase I
Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Evaluate the Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Subjects and Patients With Hypertension
Resource links provided by NLM:
MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure
Drug Information available for: Isosorbide-5-mononitrate Amlodipine Isosorbide dinitrate Amlodipine besylate Isosorbide
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
•The correlation between CBP (central blood pressure) and PBP (brachial pulse pressure) effects, during a single dose ISMN treatment measured from baseline over the 12 hour observation period [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Estimated Enrollment: 34
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sequence 1: Experimental
Placebo-ISMN ER-Amlodipine Drug: Placebo
Placebo, once daily during 4 weeks of treatment
Drug: Comparator: Amlodipine
Amlodipine 10 mg, single daily dose
Drug: Comparator: ISMN ER
ISMN ER 30 mg, single daily dose
Sequence 2: Experimental
ISMN ER-Amlodipine-Placebo Drug: Placebo
Placebo, once daily during 4 weeks of treatment
Drug: Comparator: Amlodipine
Amlodipine 10 mg, single daily dose
Drug: Comparator: ISMN ER
ISMN ER 30 mg, single daily dose
Sequence 3: Experimental
Amlodipine-Placebo-ISMN ER Drug: Placebo
Placebo, once daily during 4 weeks of treatment
Drug: Comparator: Amlodipine
Amlodipine 10 mg, single daily dose
Drug: Comparator: ISMN ER
ISMN ER 30 mg, single daily dose
Sequence 4: Experimental
ISMN ER-Placebo-Amlodipine Drug: Placebo
Placebo, once daily during 4 weeks of treatment
Drug: Comparator: Amlodipine
Amlodipine 10 mg, single daily dose
Drug: Comparator: ISMN ER
ISMN ER 30 mg, single daily dose
Sequence 5: Experimental
Placebo-Amlodipine-ISMN ER Drug: Placebo
Placebo, once daily during 4 weeks of treatment
Drug: Comparator: Amlodipine
Amlodipine 10 mg, single daily dose
Drug: Comparator: ISMN ER
ISMN ER 30 mg, single daily dose
Sequence 6: Experimental
Amlodipine-ISMN ER-Placebo Drug: Placebo
Placebo, once daily during 4 weeks of treatment
Drug: Comparator: Amlodipine
Amlodipine 10 mg, single daily dose
Drug: Comparator: ISMN ER
ISMN ER 30 mg, single daily dose
Eligibility
Ages Eligible for Study: 30 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
•Patient is a male or female between 30 and 65 years of age (inclusive) at the pre-study (screening) Female patient of childbearing potential must have a negative pregnancy test
•Patient has a brachial systolic blood pressure >130 and <180 mm Hg
•Patient has a Body Mass Index (BMI) that is >20 and <35 kg/m^2
•Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Exclusion Criteria:
•Female patient is pregnant or lactating
•Patient anticipates the use of NSAIDs other than acetaminophen
•Patient is currently a user (including "recreational use") of any illicit drugs, has a history of drug or alcohol abuse within approximately 2 years, or has a positive prestudy urine drug screen
•Patient has a condition for which there is a warning, contraindication, or precaution against the use of ISMN ER including: acute myocardial infarction or congestive heart failure, hypotension, volume depletion, and pregnancy
•Patient has a history of significant drug allergy or any clinically significant adverse experience of a serious nature related to the administration of either a marketed or an investigational drug, including nitrates, nitrites, Amlodipine, and ISMN ER
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130168
Contacts
Contact: Toll Free Number 1-888-577-8839
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
More Information
No publications provided
Responsible Party: Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
ClinicalTrials.gov Identifier: NCT01130168 History of Changes
Other Study ID Numbers: 2010_537, 166
Study First Received: May 19, 2010
Last Updated: May 26, 2010
Health Authority: United States: Food and Drug Administration
Additional relevant MeSH terms:
Antihypertensive Agents
Isosorbide
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Isosorbide-5-mononitrate
Diuretics, Osmotic
Physiological Effects of Drugs
Diuretics
Vascular Diseases
Calcium Channel Blockers
Isosorbide Dinitrate
Cardiovascular Agents
Pharmacologic Actions
Nitric Oxide Donors
Amlodipine
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension
ClinicalTrials.gov processed this record on July 12, 2010
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