HealthyPhase 1NCT00703703
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
A Phase 1 study testing Darifenacin and Tolterodine in people with Healthy, run by Novartis at 21 sites in United States.
Trial summary
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Darifenacin and Tolterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 21 sitesUnited States
- Study dates
- May 2008to Oct 2008
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and females ≥ 50 years
- Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2
Who cannot join
- Known or suspected allergy to tolterodine ER or darifenacin or their components
- Subjects with irregular day and night patterns such as night shift workers
- Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.)
- Medication with potential known to affect heart rate
- History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin
- Pregnant or nursing women
- Subjects with diseases such as urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, severe renal insufficiency, etc.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Investigative Site
Burlington, North Carolina
Investigative Site
Fort Myers, Florida
Investigative Site
Greensboro, North Carolina
Investigative Site
Hackensack, New Jersey
Investigative Site
Jacksonville, Florida
Investigative Site
Jupiter, Florida
Investigative Site
Knoxville, Tennessee
Investigative Site
Little Rock, Arkansas
Investigative Site
Miami, Florida
Investigative Site
Morgantown, West Virginia
Investigative Site
Oklahoma City, Oklahoma
Investigative Site
Orlando, Florida
Investigative Site
Overland Park, Kansas
Investigative Site
Phoenix, Arizona
Investigative Site
Riverdale, Maryland
Investigative Site
San Diego, California
Investigative Site
Springfield, Missouri
Investigative Site
Tempe, Arizona
Investigative Site
Topeka, Kansas
Investigative Site
Washington D.C., District of Columbia
Investigative Site
Wellesley Hills, Massachusetts
About this study
Official title: A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older
- Conditions
- Healthy
- Being tested
- Darifenacin, Tolterodine, Placebo
- Keywords
- Heart rate, overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DarifenacinDrug
Also called Enablex
Darifenacin tablets 15 mg once daily
TolterodineDrug
Also called Detrol LA
Tolterodine extended release (ER) 4 mg once daily
PlaceboDrug
Placebo tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Darifenacin Receives: Drug: Darifenacin |
| 2 | Active comparator | Tolterodine Receives: Drug: Tolterodine |
| 3 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7
Measured: 7 days
Secondary outcomes (1)
Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703703
- Sponsor's protocol ID
- CDAR328A2414
- Status last verified
- Aug 2012
- First submitted
- 19 Jun 2008
- Last updated
- 2 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-way Cross-over, Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess Pharmacologic Effects of a 7-day Exposure to Darifenacin 15 mg o.d. and Tolterodine ER 4 mg o.d. on Cardiovascular Parameters in Healthy Subjects 50 Years of Age and Older
- ClinicalTrials.gov ID
- NCT00703703
- Acronym / sponsor ID
- CDAR328A2414
- Conditions
- Healthy
- Keywords
- Heart rate, overactive bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- May 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the pharmacologic effects of exposure to darifenacin and tolterodine on cardiovascular parameters in healthy subjects 50 years of age and older
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DarifenacinDarifenacin |
| 2 | Active comparator | Drug: TolterodineTolterodine |
| 3 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy males and females ≥ 50 years
- Body mass index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2
Key exclusion criteria (8 listed)
- Known or suspected allergy to tolterodine ER or darifenacin or their components
- Subjects with irregular day and night patterns such as night shift workers
- Significant medical problems know to affect heart rate (ie., hypertension, hypotension, history of heart failure, history of pulmonary disease, etc.)
- Medication with potential known to affect heart rate
- History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DarifenacinAlso: EnablexDarifenacin tablets 15 mg once daily | Drug | 1 |
| TolterodineAlso: Detrol LATolterodine extended release (ER) 4 mg once daily | Drug | 2 |
| PlaceboPlacebo tablet once daily | Drug | 3 |
Primary outcome
Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7
Time frame: 7 days
1 secondary outcome
Effects of darifenacin and tolterodine compared to placebo on mean heart rate per 24 hours, at baseline and Day 7 Effects of darifenacin, tolterodine and placebo on other cardiovascular parameters at baseline and Day 7
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Darifenacin and Tolterodine in people with Healthy, run by Novartis at 21 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 2 inclusion and 8 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 2 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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?
Mean heart rate per 24 hours following exposure to darifenacin 15 mg o.d. and tolterodine ER 4 mg o.d., at baseline and Day 7 (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2012.