The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
NCT ID: NCT01130168
Last Updated: 2015-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
38 participants
INTERVENTIONAL
2010-05-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Placebo/ISMN ER/Amlodipine (Sequence 1)
Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
ISMN ER/Amlodipine/Placebo (Sequence 2)
Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Amlodipine/Placebo/ISMN ER (Sequence 3)
Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
ISMN ER/Placebo/Amlodipine (Sequence 4)
Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Placebo/Amlodipine/ISMN ER (Sequence 5)
Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Amlodipine/ISMN ER/Placebo (Sequence 6)
Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Interventions
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Placebo
Placebo, capsule taken orally once daily during 4 weeks of treatment
Comparator: Amlodipine
Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
Comparator: ISMN ER
ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Female participant of childbearing potential must have a negative pregnancy test
* Participant has a brachial systolic blood pressure \>130 mm Hg
and \<180 mm Hg
* Participant has a Body Mass Index (BMI) that is \>20 kg/m\^2 and \<35 kg/m\^2
* Participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
Exclusion Criteria
* Participant anticipates the use of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) other than acetaminophen
* Participant 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
* Participant 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
* Participant 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
30 Years
65 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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2010_537
Identifier Type: -
Identifier Source: secondary_id
0000-166
Identifier Type: -
Identifier Source: org_study_id
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