The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)

Browse trials for

• Hypertension 6,689

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 13 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Study arms

• Active comparator
  1

  losartan 100 mg

  Drug: losartan potassium

• Active comparator
  2

  ISMN 60 mg

  Drug: Comparator: isosorbide mononitrate (ISMN)

• Active comparator
  3

  losartan 100 mg + ISMN 15 mg

  Drug: Comparator: losartan + ISMN

• Active comparator
  4

  losartan 100 mg + ISMN 60 mg

  Drug: Comparator: losartan + ISMN

• Placebo comparator
  5

  Placebo

  Drug: Comparator: Placebo

Interventions

• Druglosartan potassium

  Single dose losartan 100 mg in one of five treatment periods

  Also known as: COZAAR

• DrugComparator: isosorbide mononitrate (ISMN)

  Single dose ISMN 60 mg in one of five treatment periods

  Also known as: IMDUR

• DrugComparator: losartan + ISMN

  Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods

• DrugComparator: losartan + ISMN

  Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods

• DrugComparator: Placebo

  Single dose placebo only in one of five treatment periods

Primary outcomes

1. Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg Plus ISMN 60 mg Versus Single Dose of Losartan 100 mg

   The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.

   Time frame: Baseline and 10 hours postdose

2. Mean Augmentation Index Percent Change From Baseline After Single Doses of Losartan 100 mg + ISMN 60 mg Versus Single Dose of Placebo

   The augmentation index (AIx) is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. A mathematical transfer function translated the peripheral wave form into a central waveform using an FDA approved process based on directly recorded arterial pressure values. The mean AIx for each subject was estimated as a time-weighted average over the 10-hour post dose observation period and expressed as a change from baseline.

   Time frame: Baseline and 10 hours postdose

Baseline characteristics

Publications

• Kaufman R, Nunes I, Bolognese JA, Miller DL, Salotti D, McCarthy JM, Smith WB, Herman GA, Feig PU. Single-dose effects of isosorbide mononitrate alone or in combination with losartan on central blood pressure. J Am Soc Hypertens. 2010 Nov-Dec;4(6):311-8. doi: 10.1016/j.jash.2010.10.004. PubMed 21130977 ↗