HealthyPhase 4NCT00413790
Pharmacologic Effects of Darifenacin and Tolterodine on Cardiovascular Parameters in Healthy Subjects
A Phase 4 study testing Darifenacin and Tolterodine in people with Healthy, run by Novartis at 12 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 older
- 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
- 162 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2006to Sep 2007
- Phase
- Phase 4
- 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
- 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.)
- 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Investigative Site
Austin, Texas, 78752
Investigative Site
Buffalo, New York, 14202
Investigative Site
Dallas, Texas, 75235
Investigative Site
Hackensack, New Jersey, 07601
Investigative Site
Jacksonville, Florida, 32216
Investigative Site
Jupiter, Florida, 33458
Investigative Site
Madisonville, Kentucky, 42431
Investigative Site
Overland Park, Kansas, 66215
Investigative Site
San Diego, California, 92103
Investigative Site
Scottsdale, Arizona, 85251
Investigative Site
Tempe, Arizona, 85282
Investigative Site
Wellesley Hills, Massachusetts, 02481
About this study
Official title: A 3-Way Cross-Over, Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the 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
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
Secondary outcomes (2)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2006 (estimated)
- Study startNov 2006
- Study completionSep 2007
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Investigators
- Novartis Pharmaceuticals Corp., Study chair, NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413790
- Sponsor's protocol ID
- CDAR328A2413
- Status last verified
- Jan 2008
- First submitted
- 19 Dec 2006
- Last updated
- 15 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2008. 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 the 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
- NCT00413790
- Acronym / sponsor ID
- CDAR328A2413
- Conditions
- Healthy
- Keywords
- Heart rate, overactive bladder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Procter and Gamble
- Study start
- Nov 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Dec 2006 (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
- 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 (7 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.)
- History of any malignancy within the past 5 years, with the exception of localized basal cell carcinoma of the skin
- Pregnant or nursing women
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 |
| TolterodineTolterodine 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
2 secondary outcomes
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
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 15 Jan 2008.
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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 Corp. study chair
NPC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darifenacin and Tolterodine in people with Healthy, run by Novartis at 12 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 7 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 15 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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. 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 15 Jan 2008.