Phase 1
N=38
The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01130168 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: Primary: 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 — -11.1; -0.7; 2.1 percent — p=<0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo (Drug); Comparator: Amlodipine (Drug); Comparator: ISMN ER (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-11.1; -0.7; 2.1 | <0.0005 sig |
| PRIMARY Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment |
2.5; -4.7; 1.2 | 0.407 |
| PRIMARY TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment |
-14.7; -3.6; 2.7 | <0.0005 sig |
| PRIMARY Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment |
-0.7; -12.9; 3.2 | 0.186 |
| PRIMARY TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment |
-8.2; -2.1; 1.1 | <0.0005 sig |
| PRIMARY Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment |
-0.7; -7.7; 1.1 | 0.428 |
| PRIMARY TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment |
-12.1; -3.1; 1.7 | <0.0005 sig |
| PRIMARY Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment |
-0.6; -11.4; 3.9 | 0.112 |
| PRIMARY TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment |
-8.0; -2.0; 1.0 | <0.0005 sig |
| PRIMARY Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment |
-1.4; -7.5; 1.0 | 0.267 |
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 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
Data sourced from ClinicalTrials.gov (NCT01130168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.