The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Placebo (Drug); Comparator: Amlodipine (Drug); Comparator: ISMN ER (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This study will test the relationship between CBP (central blood pressure) and PBP
(peripheral blood pressure) effects after single and multiple doses of Isosorbide
mononitrate extended release (ISMN ER) or Amlodipine besylate in participants with
hypertension.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of TreatmentChange From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment
Eligibility
Minimum age: 30 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant is a male or female between 30 and 65 years of age (inclusive) at the
pre-study (screening)
- 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:
- Female Participant is pregnant or lactating
- 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
Locations and Contacts
Additional Information
Starting date: May 2010
Last updated: April 21, 2015
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