Skip to main content
OpenTrials
Completed

NCT Number: NCT01130168

The Effects of Antihypertensive Agents on Central Blood Pressure in Healthy Participants and Participants With Hypertension (MK-0000-166) (COMPLETED)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo, capsule taken orally once daily during 4 weeks of treatment

Comparator: Amlodipine

Drug

Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks

Comparator: ISMN ER

Drug

ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks

Primary outcomes

  1. 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

    Time frame: Baseline (0 hrs), 12 hours post-dose (Day 1)

    The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Single dose effects on AIx were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:

    HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses.

  2. Change From Baseline (0 Hours) to Week 4 in Heart-Rate-Corrected AIx After Multiple Doses of Treatment

    Time frame: Baseline (0 hrs), 24 hours after the Day 28 dose

    The augmentation index (AIx) is a measure of systemic arterial stiffness, and is the ratio of augmented aortic pressure (Δ P) to central pulse pressure expressed as a percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Because heart rate (HR) affects AIx, AIx was corrected to a HR of 75 beats per minute (bpm) as follows:

    HR-corrected AIx = -0.39 x (75 - HR) + AIx. This value was used for all AIx analyses.

  3. TWA Change From Baseline (0 Hours) to 12 Hours in Central Systolic Blood Pressure (SBP) After A Single Dose of Treatment

    Time frame: Baseline (0 hrs), 12 hours post-dose (Day 1)

    Central SBP was measured by the SphygmoCor® device. Single dose effects on central SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.

  4. Change From Baseline (0 Hours) to Week 4 in Central SBP After Multiple Doses of Treatment

    Time frame: Baseline (0 hrs), 24 hours after the Day 28 dose

    Central SBP was measured by the SphygmoCor® device. Central SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.

  5. TWA Change From Baseline (0 Hours) to 12 Hours in Central Diastolic Blood Pressure (DBP) After A Single Dose of Treatment

    Time frame: Baseline (0 hrs), 12 hours post-dose (Day 1)

    Central DBP was measured by the SphygmoCor® device. Single dose effects on central DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.

  6. Change From Baseline (0 Hours) to Week 4 in Central DBP After Multiple Doses of Treatment

    Time frame: Baseline (0 hrs), 24 hours after the Day 28 dose

    Central DBP was measured by the SphygmoCor® device. Central DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.

  7. TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral SBP After A Single Dose of Treatment

    Time frame: Baseline (0 hrs), 12 hours post-dose (Day 1)

    Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral SBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.

  8. Change From Baseline (0 Hours) to Week 4 in Peripheral SBP After Multiple Doses of Treatment

    Time frame: Baseline (0 hrs), 24 hours after the Day 28 dose

    Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral SBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.

  9. TWA Change From Baseline (0 Hours) to 12 Hours in Peripheral DBP After A Single Dose of Treatment

    Time frame: Baseline (0 hrs), 12 hours post-dose (Day 1)

    Peripheral DBP was measured by Brachial Sphygmomanometer (standard cuff). Single dose effects on peripheral DBP were estimated as a time-weighted average change from baseline over the 12-hour post single dose observation period.

  10. Change From Baseline (0 Hours) to Week 4 in Peripheral DBP After Multiple Doses of Treatment

    Time frame: Baseline (0 hrs), 24 hours after the Day 28 dose

    Peripheral SBP was measured by Brachial Sphygmomanometer (standard cuff). Peripheral DBP was measured at baseline and at 24 hours post dose on Day 28 (Week 4) and expressed as a change from baseline.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 25, 2010
Registry last updated
Oct 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.