Clinical trial NCT01130168: The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-05-25
Enrollment: 38
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Time-weighted Average (TWA) Change From Baseline (0 Hours) to 12 Hours in Heart-Rate-Corrected Augmentation Index (AIx) After A Single Dose of Treatment
timeFrame: Baseline (0 hrs), 12 hours post-dose (Day 1)
measure: Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment
timeFrame: Baseline (0 hrs), 24 hours after the Day 28 dose
measure: TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment
timeFrame: Baseline (0 hrs), 12 hours post-dose (Day 1)
measure: Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment
timeFrame: Baseline (0 hrs), 24 hours after the Day 28 dose
measure: TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment
timeFrame: Baseline (0 hrs), 12 hours post-dose (Day 1)
measure: Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment
timeFrame: Baseline (0 hrs), 24 hours after the Day 28 dose
measure: TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment
timeFrame: Baseline (0 hrs), 12 hours post-dose (Day 1)
measure: Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment
timeFrame: Baseline (0 hrs), 24 hours after the Day 28 dose
measure: TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment
timeFrame: Baseline (0 hrs), 12 hours post-dose (Day 1)
measure: Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment
timeFrame: Baseline (0 hrs), 24 hours after the Day 28 dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: