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Erectile DysfunctionPhase 1NCT01348880

Vardenafil ODT (Orally Disintegrating Tablet) - Nifedipine Interaction Study

A Phase 1 study testing Vardenafil ODT, (Staxyn, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo… Read more about this study

Who is it for?
Ages 65 to 80 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Vardenafil ODT, (Staxyn, BAY38-9456)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
2 sitesUnited States
Study dates
May 2011to Dec 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • Men only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Subjects must fulfill all of the following criteria before being included in the treatment period i.e., before receiving any dose of the study related medication (Sponsor supplied Procardia XL, or vardenafil Orally Disintegrating Tablet (ODT) /placebo tablets):
  • The informed consent must be signed before any study specific tests or procedures are done
  • Male gender
  • Diagnosis of both essential hypertension (HTN) and erectile dysfunction (ED)
  • High blood pressure, or hypertension, is defined in an adult as a systolic pressure of 140 mm Hg or higher and/or a diastolic pressure of 90 mm Hg or higher. As stated in the current American Heart Association guidelines.
  • Documented ED for more than 6 months according to the National Institutes of Health (NIH) Consensus statement (the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). The diagnosis for ED will be confirmed using the five-item version (Rosen RC) of the International Index of Erectile Function (IIEF-5), see Appendix 14.4. The total IIEF-5 score must be at least 8, and not exceed 19. Subjects must have used at least one Phosphodiesterase-5 (PDE-5) inhibitor, such as Viagra, Levitra or Cialis at some time prior to entry in this study.
  • Age: 65 to 80 years (inclusive) at the first screening examination / visit
  • Body mass index (BMI): above/equal 18 and below/equal 32 kg / m²

Who cannot join

  • Subjects are to be excluded from the study if they display any of the following criteria:
  • Medical and surgical history
  • Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal. This includes severe renal impairment (on dialysis or not) and moderate or severe hepatic disease.
  • Known hypersensitivity to calcium channel blockers (active substances or excipients of the tablet preparations)
  • Known hypersensitivity to PDE-5 inhibitors, such as Viagra, Levitra or Cialis (active substances or in some instances, excipients of the tablet preparations should be considered as possible allergens, e.g., lactose, aspartame)
  • Known severe allergies, non-allergic drug reactions, or multiple drug allergies
Show all 24Show fewer
  • Recent history (within 6 months) of myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), stenting, or cerebrovascular accident (CVA)
  • Known left ventricular outflow syndrome (LVO)
  • History of significant coronary artery disease, e.g., angina
  • Congenital or acquired prolonged QT syndrome
  • Congestive heart failure (CHF) [NYHA Class 3 or 4]
  • History of adult epilepsy or other seizure disorders
  • History of retinitis pigmentosa
  • Use of any anti-hypertensive medication other than the calcium channel blocker, Procardia XL (nifedipine), supplied by the sponsor, during the study
  • Any drug known to induce cytochrome P450 (CYP) enzymes (eg rifampicin, carbamazepine, phenytoin, bosentan, dexamethasone, barbiturates, St. John's Wort [hypericum perforatum])
  • Any drug known to inhibit CYP enzymes: specifically potent or moderate cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors such as HIV protease inhibitors (e.g. ritonavir, indinavir, saquinavir, atazanavir), ketoconazole, itraconazole, clarithromycin and erythromycin
  • Use of nitroglycerin or any form of nitrates is not allowed
  • All alpha-blockers (e.g., Hytrin, Flomax, Uroxatral) are prohibited Electrocardiogram (ECG), blood pressure, heart rate
  • Clinically relevant findings in the ECG such as a second- or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTc-interval over 450 msec
  • Systolic blood pressure below 110 or above 150 mmHg on anti-hypertensive therapy
  • Diastolic blood pressure below 60 or above 95 mmHg on anti-hypertensive therapy
  • Heart rate below 40 or above 95 beats / min on anti-hypertensive therapy
  • Serum creatinine > 2.5 mg/dL at Screening
  • HbA1c > 8% indicative of uncontrolled DM at Screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Study site

    Knoxville, Tennessee, 37920

  • Study site

    Miami, Florida, 33014

Other trials in United States

About this study

Official title: A Double-Blind Study to Evaluate the Pharmacodynamic Interaction Between 10 mg Vardenafil ODT (Orally Disintegrating Tablet) and Procardia XL® (Nifedipine GITS) in Elderly Male Patients With Both Hypertension and Erectile Dysfunction

The study will be conducted as a multi-center, randomized, double-blinded, placebo controlled, crossover design. The investigational drug (vardenafil ODT (Orally Disintegrating Tablet)/placebo) will be given as a single administration at a dose of 10 mg vardenafil ODT during Period 1 or 2; the blinded matching placebo will be given as a single administration during the opposing period. The random code will determine the order of active drug (vardenafil ODT) and placebo for each subject. Blood pressure and heart rate profiles will be recorded by automated device pre-dose for 8 hours post-dose during Periods 1 and 2. The non investigational drug product (vasodilator), Procardia XL, will be background treatment for hypertension, taken daily by each subject. All subjects must be stable on the vasodilator for at least 4 weeks prior to Day 1 of Period 1. Special conditions for this study include the requirement that all subjects will be male, are between the ages of 65 and 80 years, and will have a diagnosis of erectile dysfunction (ED), as well as hypertension. Planned sample size will be 40 subjects evaluable for the primary analysis. Of the 40 subjects valid for this analysis, 20 will be between the ages of 65 and 69 years, and 20 subjects will be between the ages of 70 and 80 years. The total duration of the study will be approximately one year from first subject treated to last subject treated, including replacement of any subjects who fail to complete both periods of crossover dosing.

Being tested
Vardenafil ODT, (Staxyn, BAY38-9456), Placebo
Keywords
drug-drug interaction
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vardenafil ODT, (Staxyn, BAY38-9456)Drug

    Single dose of 10 mg of vardenafil ODT, taken without water

  • PlaceboDrug

    Single dose of placebo to match 10 mg vardenafil ODT. taken without water

Study groups in NCT01348880
Study groupRoleWhat they receive
Arm1ExperimentalNot described
Receives: Drug: Vardenafil ODT, (Staxyn, BAY38-9456)
Arm2Placebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary pharmacodynamic variable (endpoint) is the placebo-corrected mean maximal decrease in supine systolic blood pressure from baseline (1 hour before dose) to within 8 hours of dosing with 10 mg ODT formulation of vardenafil HCl and nifedipine.

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine.

Secondary outcomes (8)

  1. Mean maximal decrease in standing SBP

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine

  2. Mean maximal decrease in standing diastolic blood pressure (DBP)

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine

  3. Mean maximal decrease in supine DBP

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine

  4. Mean maximal orthostatic change in SBP (the supine SBP minus the standing SBP)

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine

  5. Mean maximal increase in supine and standing heart rate

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine

  6. Mean area under effect curve (AUEC) in standing and supine systolic and diastolic blood pressure, and heart rate

    Measured: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine

  7. Safety parameters

    Safety parameters included physical examinations, adverse events, laboratory values, electrocardiogram, concomitant medications, and vital signs

    Measured: up to end of study

  8. Pharmacokinetics parameter

    Measured: 1 and 2 weeks prior to the Day 1 dosing of the combination of nifedipine/vardenafil as well as at Visit 4 and Visit 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01348880
Sponsor's protocol ID
15345
Status last verified
May 2014
First submitted
4 May 2011
Last updated
19 May 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vardenafil ODT, (Staxyn, BAY38-9456) in people with Erectile Dysfunction, run by Bayer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary pharmacodynamic variable (endpoint) is the placebo-corrected mean maximal decrease in supine systolic blood pressure from baseline (1 hour before dose) to within 8 hours of dosing with 10 mg ODT formulation of vardenafil HCl and nifedipine. (time frame: Up to 8 hours of combination dosing of vardenafil ODT and nifedipine.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01348880.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.

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