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CompletedNCT00421733VITALUpdated Jan 20, 2012Results posted

The Effect of Paricalcitol Capsules on Reducing Albuminuria in Patients With Type 2 Diabetic Nephropathy Being Treated With Renin-angiotensin System Inhibitors

A Phase 2 interventional study of Zemplar (paricalcitol ) capsules and Zemplar (paricalcitol) capsules in Diabetic Nephropathy and Chronic Kidney Disease, sponsored by Abbott. Completed at 72 sites in 10 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-01-20.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
281
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The study objective was to evaluate the safety of paricalcitol capsules and the efficacy of paricalcitol capsules for albuminuria reduction in patients with Chronic Kidney Disease (CKD) who have Type 2 diabetic nephropathy and are receiving optimal angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB) therapy.

02

Conditions studied

  • Diabetic Nephropathy
  • Chronic Kidney Disease

Keywords

  • Type 2 Diabetic Nephropathy
03

In context

Diabetic Nephropathies

544 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's enrollment of 281 is above the median of 80 across 385 interventional studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.

Browse Abbott studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female participant >= 20 years old.
  • Participant has Type 2 Diabetes Mellitus and has been treated with at least one anti-hyperglycemic medication within the 12 months prior to the Screening Phase
  • Participant has been receiving a stable dose (i.e., same type and regimen) of ACEi and/or ARB for at least three months prior to the Screening Phase. However, participant may have switched to different brands but at equivalent doses during the three months prior to the Screening Phase.
  • Participant is not expected to begin dialysis for at least 6 months.
  • If female, participant is not breast feeding or is not pregnant.

  • For entry into the Treatment Phase, the participant must satisfy the following criteria based on the Screening laboratory values:

    • Estimated glomerular filtration rate (GFR) between 15-90 mL/min/1.73m2 by simplified Modification in Diet in Renal Disease (MDRD) formula
    • Urinary albumin to creatinine ratio (UACR) between 100 and 3000 mg/g as determined by the mean of the three first morning void urine specimens obtained within one week of each other
    • Corrected serum calcium level \<= 9.8 mg/dL
    • intact parathyroid hormone (iPTH) value between 35-500 pg/mL
    • Glycosylated hemoglobin A1c (HbA1c) \<= 12%
    • Serum albumin > 3.0 g/dL
    • Negative urine pregnancy test for female participants

Exclusion criteria

Exclusion Criteria:

  • Participant has previously been on prescription-based vitamin D therapy within the six months prior to the Screening Phase.
  • Participant has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
  • Participant has primary glomerulonephritis or secondary nephritis in addition to diabetic nephropathy.
  • Participant has had acute renal failure within 12 weeks of the Screening Phase, defined as an acute rise (of >= 0.5 mg/dL) in serum creatinine to > 4 mg/dL.
  • Participant has chronic gastrointestinal disease.
  • Participant has secondary hypertension.
  • Participant has poorly controlled hypertension.
  • Participant has a history of kidney stones.
  • Participant has a history of drug or alcohol abuse within six months prior to the Screening Phase.
  • Participant has evidence of poor compliance with diet or medication.
  • Participant has received any investigational drug within 30 days prior to study drug administration.
  • Participant is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical glucocorticoids), or other drugs that may affect calcium, or bone metabolism, other than calcium containing phosphate binder or female participants on stable (same dose and product for three months) estrogen and/or progestin therapy.
  • For any reason, participant is considered by the Investigator to be an unsuitable candidate to receive paricalcitol capsules or is put at risk by study procedures.
  • Participant is known to be human immunodeficiency virus (HIV) positive.
  • Participant has used known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
281 participants (actual)

Study arms

  • Active comparator
    Paricalcitol 1 mcg

    One paricalcitol 1 mcg capsule and one matching placebo capsule per dose

    Drug: Zemplar (paricalcitol ) capsules

  • Active comparator
    Paricalcitol 2 mcg

    Two paricalcitol 1 mcg capsules per dose

    Drug: Zemplar (paricalcitol) capsules

  • Placebo comparator
    Placebo

    Two placebo capsules per dose

    Drug: Placebo

Interventions

  • DrugZemplar (paricalcitol ) capsules

    Group 2 - paricalcitol 1 mcg capsules once daily (one paricalcitol 1 mcg capsule once daily and one matching placebo capsule once daily)

    Also known as: ABT-358, paricalcitol, Zemplar

  • DrugZemplar (paricalcitol) capsules

    Group 3 - paricalcitol 2 mcg capsules once daily (two paricalcitol 1 mcg capsules once daily)

    Also known as: ABT-358, paricalcitol, Zemplar

  • DrugPlacebo

    Group 1 - Placebo once daily (two placebo capsules once daily)

06

What researchers measure

Primary outcomes

  1. Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).

    UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.

    Time frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

Secondary outcomes

  1. Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.

    Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

    Time frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

  2. Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.

    The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

    Time frame: Baseline (within 1 week prior to first treatment) through 24 weeks of treatment

  3. Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.

    Change is mean change in picograms of iPTH per milliliter of serum.

    Time frame: Baseline (screening period) through 24 weeks of treatment

07

Results

Posted Sep 14, 2010

Participant flow

Participant flow — Overall Study
MilestoneParicalcitol 1 McgParicalcitol 2 McgPlacebo
Started939593
Completed786973
Not completed152620
Withdrew: Adverse event492
Withdrew: Lost to follow-up124
Withdrew: Withdrawal by subject127
Withdrew: Death030
Withdrew: Required dialysis100
Withdrew: Administrative200
Withdrew: Did not satisfy entry criteria132
Withdrew: Sponsor request103
Withdrew: Protocol deviation472

Outcome measures

PrimaryChange From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).

UACR is defined as the ratio: milligram of albumin per gram of creatinine. Baseline UACR was determined as the mean of the 3 UACR measurements from FMV urine collections obtained within 1 week prior to the day of the first dose of study drug. The last on-treatment measurement was the mean of the 3 UACR measurements obtained from FMV urine collections obtained within 1 week of the final week of treatment. The UACR data were log transformed prior to analysis.

Time frame:
Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
Reported as:
Mean · log milligram/gram creatinine
Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).
log milligram/gram creatininePlaceboCombined Paricalcitol 1 Mcg and 2 McgParicalcitol 1 McgParicalcitol 2 Mcg
Change From Baseline to the Last On-treatment Measurement in Urine Albumin to Creatinine Ratio (UACR) Levels Determined From the First Morning Void (FMV) Urine Collections Comparing Placebo to the Combined Paricalcitol Treatment Groups (1 Mcg and 2 Mcg).-0.03 ± 0.61-0.18 ± 0.70-0.15 ± 0.72-0.22 ± 0.69
Statistical analysis
  • Placebo vs Combined Paricalcitol 1 Mcg and 2 Mcg · ANCOVA · p = 0.071 (There were no P-value adjustments for multiple comparisons.)1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.
  • Placebo vs Paricalcitol 1 Mcg · ANCOVA · p = 0.229 (There were no P-value adjustments for multiple comparisons.)1-way ANCOVA with treatment group as the factor and baseline FMV UACR as the covariate.
  • Placebo vs Paricalcitol 2 Mcg · ANCOVA · p = 0.053 (There were no P-value adjustments for multiple comparisons.)1-way ANCOVA using treatment group as the factor and baseline FMV UACR as the covariate.
SecondaryNumber of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.

Number of participants whose last on-treatment albumin to creatinine ratio (UACR) value was reduced at least 15% from the baseline value. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

Time frame:
Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
Reported as:
Number · Participants
Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.
ParticipantsParicalcitol 1 McgParicalcitol 2 McgPlacebo
Number of Participants Achieving a 15% or Greater Reduction From Baseline to Last On-treatment Urine Albumin to Creatinine Ratio (UACR) Levels.485135
Statistical analysis
  • Paricalcitol 1 Mcg vs Placebo · Fisher Exact · p = 0.102
  • Paricalcitol 2 Mcg vs Placebo · Fisher Exact · p = 0.038
SecondaryChange From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.

The change is mean change from baseline to the last on-treatment value, with the data being log transformed prior to analysis. Albumin values were determined from 24-hour urine collections from the baseline and last on-treatment visits.

Time frame:
Baseline (within 1 week prior to first treatment) through 24 weeks of treatment
Reported as:
Mean · log milligrams of albumin per 24 hours
Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.
log milligrams of albumin per 24 hoursParicalcitol 1 McgParicalcitol 2 McgPlacebo
Change From Baseline to the Last On-treatment Measurement in Albumin Levels Determined From 24-hour Urine Collection.-0.10 ± 0.73-0.44 ± 0.90-0.08 ± 0.73
Statistical analysis
  • Paricalcitol 1 Mcg vs Placebo · ANCOVA · p = 0.855 · Mean difference (net): -0.02 · 95% CI -0.26 to 0.222-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction
  • Paricalcitol 2 Mcg vs Placebo · ANCOVA · p = 0.009 · Mean difference (net): -0.33 · 95% CI -0.57 to -0.082-way ANCOVA: baseline UACR as covariate; fixed factors for treatment group, stratification level, and treatment by stratification level interaction
SecondaryChange From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.

Change is mean change in picograms of iPTH per milliliter of serum.

Time frame:
Baseline (screening period) through 24 weeks of treatment
Reported as:
Mean · picogram/milliliter
Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.
picogram/milliliterParicalcitol 1 McgParicalcitol 2 McgPlacebo
Change From Baseline to the Last On-treatment Observation in Intact Parathyroid Hormone (iPTH) Levels.-26.7 ± 55.2-50.7 ± 63.118.3 ± 55.3
Statistical analysis
  • Paricalcitol 1 Mcg vs Placebo · ANCOVA · p = <0.0011-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.
  • Paricalcitol 2 Mcg vs Placebo · ANCOVA · p = <0.0011-way ANCOVA with treatment group as the factor and baseline iPTH as covariate.

Adverse events

Collected over up to 24 weeks. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Paricalcitol 1 Mcg—13/93 (14%)38/93 (40.9%)
Paricalcitol 2 Mcg—19/95 (20%)46/95 (48.4%)
Placebo—12/93 (12.9%)46/93 (49.5%)
Most frequent serious events
Showing 10 of 54
Most frequent serious events
EventParicalcitol 1 McgParicalcitol 2 McgPlacebo
GastritisGastrointestinal disorders0/930/952/93
HypoglycaemiaMetabolism and nutrition disorders2/930/950/93
Acute myocardial infarctionCardiac disorders0/932/950/93
Fluid overloadMetabolism and nutrition disorders0/932/950/93
Cerebrovascular accidentNervous system disorders0/932/950/93
Renal failure acuteRenal and urinary disorders1/932/951/93
HypotensionVascular disorders0/932/950/93
AnaemiaBlood and lymphatic system disorders0/931/951/93
Angina pectorisCardiac disorders1/930/950/93
BradycardiaCardiac disorders0/930/951/93
Most frequent other events
Showing 10 of 28
Most frequent other events
EventParicalcitol 1 McgParicalcitol 2 McgPlacebo
HypertensionVascular disorders5/938/9511/93
AnemiaBlood and lymphatic system disorders5/938/955/93
DiarrhoeaGastrointestinal disorders3/931/956/93
Urinary tract infectionInfections and infestations2/936/952/93
Oedema peripheralGeneral disorders5/934/954/93
Upper respiratory tract infectionInfections and infestations5/935/954/93
Muscle spasmsMusculoskeletal and connective tissue disorders0/931/955/93
CoughRespiratory, thoracic and mediastinal disorders5/930/953/93
FatigueGeneral disorders1/935/951/93
HyperkalaemiaMetabolism and nutrition disorders3/935/954/93

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Paricalcitol 1 McgParicalcitol 2 McgPlaceboTotal
<=18 years0000
Between 18 and 65 years454744136
>=65 years484849145
Age Continuous
Age Continuous(years)Paricalcitol 1 McgParicalcitol 2 McgPlaceboTotal
Mean64.0 ± 10.1564.7 ± 9.9264.5 ± 11.2364.4 ± 10.41
Sex: Female, Male
Sex: Female, Male(Participants)Paricalcitol 1 McgParicalcitol 2 McgPlaceboTotal
Female27263386
Male666960195
Region of Enrollment
Region of Enrollment(participants)Paricalcitol 1 McgParicalcitol 2 McgPlaceboTotal
Portugal2204
United States576064181
Taiwan10141034
Greece1315
Poland44412
Spain113923
Netherlands0011
Germany48113
Italy4138
08

Study locations

72 sites
  • Site Reference ID/Investigator# 862
    Phoenix, Arizona 85012, United States
  • Site Reference ID/Investigator# 864
    Fountain Valley, California 92708, United States
  • Site Reference ID/Investigator# 7291
    Yuba City, California 95991, United States
  • Site Reference ID/Investigator# 853
    Hudson, Florida 34667, United States
  • Site Reference ID/Investigator# 867
    Lauderdale Lakes, Florida 33313, United States
  • Site Reference ID/Investigator# 857
    Pembroke Pines, Florida 33028, United States
  • Site Reference ID/Investigator# 8901
    West Palm Beach, Florida 33401, United States
  • Site Reference ID/Investigator# 7113
    Roswell, Georgia 30076, United States
  • Site Reference ID/Investigator# 2531
    Chicago, Illinois 60654, United States
  • Site Reference ID/Investigator# 3371
    Evanston, Illinois 60201, United States
  • Site Reference ID/Investigator# 869
    Indianapolis, Indiana 46202, United States
  • Site Reference ID/Investigator# 8054
    Baton Rouge, Louisiana 70808, United States
  • Site Reference ID/Investigator# 854
    Rockville, Maryland 20852, United States
  • Site Reference ID/Investigator# 6281
    Boston, Massachusetts 02215, United States
  • Site Reference ID/Investigator# 859
    Brooklyn Center, Minnesota 55430, United States
  • Site Reference ID/Investigator# 7214
    Omaha, Nebraska 68131, United States
  • Site Reference ID/Investigator# 8046
    Albany, New York 12206, United States
  • Site Reference ID/Investigator# 866
    Charlotte, North Carolina 28208, United States
  • Site Reference ID/Investigator# 8039
    Greenville, North Carolina 27834, United States
  • Site Reference ID/Investigator# 8053
    Morehead City, North Carolina 28557, United States
  • Site Reference ID/Investigator# 6626
    Winston-Salem, North Carolina 27103, United States
  • Site Reference ID/Investigator# 7495
    Carlisle, Pennsylvania 17015, United States
  • Site Reference ID/Investigator# 9061
    Dallas, Texas 75230, United States
  • Site Reference ID/Investigator# 8325
    Dallas, Texas 75231, United States
  • Site Reference ID/Investigator# 856
    Dallas, Texas 75390, United States
  • Site Reference ID/Investigator# 7494
    San Antonio, Texas 78229, United States
  • Site Reference ID/Investigator# 774
    San Antonio, Texas 78229, United States
  • Site Reference ID/Investigator# 6316
    Düsseldorf, 40210, Germany
  • Site Reference ID/Investigator# 5167
    Hanover, 30625, Germany
  • Site Reference ID/Investigator# 6302
    Ludwigshafen, 67059, Germany
  • Site Reference ID/Investigator# 6314
    Athens, 18454, Greece
  • Site Reference ID/Investigator# 6306
    Ioannina, 45500, Greece
  • Site Reference ID/Investigator# 5631
    Thessaloniki, 54636, Greece
  • Site Reference ID/Investigator# 6310
    Thessaloniki, 54642, Greece
  • Site Reference ID/Investigator# 6312
    Bergamo, 24128, Italy
  • Site Reference ID/Investigator# 6303
    Brescia, 25123, Italy
  • Site Reference ID/Investigator# 6309
    Milan, 20142, Italy
  • Site Reference ID/Investigator# 6210
    Modena, 41100, Italy
  • Site Reference ID/Investigator# 6207
    Groningen, 9713 GZ, Netherlands
  • Site Reference ID/Investigator# 6304
    Bydgoszcz, 85-094, Poland
  • Site Reference ID/Investigator# 5622
    Katowice, 40027, Poland
  • Site Reference ID/Investigator# 5203
    Szczecin, 70-111, Poland
  • Site Reference ID/Investigator# 6315
    Warsaw, 00909, Poland
  • Site Reference ID/Investigator# 6327
    Lisbon, 1069-166, Portugal
  • Site Reference ID/Investigator# 6326
    Porto, 4202-451, Portugal
  • Site Reference ID/Investigator# 6916
    Caguas, 00725, Puerto Rico
  • Site Reference ID/Investigator# 5175
    Carolina, 00983, Puerto Rico
  • Site Reference ID/Investigator# 6290
    Las Piedras, 00771, Puerto Rico
  • Site Reference ID/Investigator# 5179
    Ponce, 00716, Puerto Rico
  • Site Reference ID/Investigator# 6293
    Ponce, 00716, Puerto Rico
  • Site Reference ID/Investigator# 5173
    Ponce, 00717-0634, Puerto Rico
  • Site Reference ID/Investigator# 6300
    Ponce, 00717-1322, Puerto Rico
  • Site Reference ID/Investigator# 5168
    Ponce, 00717-2075, Puerto Rico
  • Site Reference ID/Investigator# 7298
    Rio Piedras, 00935, Puerto Rico
  • Site Reference ID/Investigator# 5170
    San Juan, 00909, Puerto Rico
  • Site Reference ID/Investigator# 7509
    San Juan, 00918, Puerto Rico
  • Site Reference ID/Investigator# 6288
    San Juan, 00921-3201, Puerto Rico
  • Site Reference ID/Investigator# 6291
    San Juan, 00936-5067, Puerto Rico
  • Site Reference ID/Investigator# 6919
    Toa Baja, 00949, Puerto Rico
  • Site Reference ID/Investigator# 6296
    Yabucoa, 00767, Puerto Rico
  • Site Reference ID/Investigator# 6569
    Barcelona, 08036, Spain
  • Site Reference ID/Investigator# 10621
    Galdakao, 48960, Spain
  • Site Reference ID/Investigator# 6330
    L'Hospitalet de, 08907, Spain
  • Site Reference ID/Investigator# 5111
    Madrid, 28041, Spain
  • Site Reference ID/Investigator# 5110
    Oviedo, 33006, Spain
  • Site Reference ID/Investigator# 6329
    Santander, 39008, Spain
  • Site Reference ID/Investigator# 11281
    Valencia, 46017, Spain
  • Site Reference ID/Investigator# 8335
    Taichung, 40764, Taiwan
  • Site Reference ID/Investigator# 7927
    Taichung, 433, Taiwan
  • Site Reference ID/Investigator# 6294
    Taipei, 10449, Taiwan
  • Site Reference ID/Investigator# 6285
    Taipei, Taiwan
  • Site Reference ID/Investigator# 6286
    Xinzhuang, Taiwan
09

References and documents

Publications

  • Coyne DW, Andress DL, Amdahl MJ, Ritz E, de Zeeuw D. Effects of paricalcitol on calcium and phosphate metabolism and markers of bone health in patients with diabetic nephropathy: results of the VITAL study. Nephrol Dial Transplant. 2013 Sep;28(9):2260-8. doi: 10.1093/ndt/gft227. Epub 2013 Jun 19. PubMed 23787544 ↗
  • de Zeeuw D, Agarwal R, Amdahl M, Audhya P, Coyne D, Garimella T, Parving HH, Pritchett Y, Remuzzi G, Ritz E, Andress D. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Lancet. 2010 Nov 6;376(9752):1543-51. doi: 10.1016/S0140-6736(10)61032-X. PubMed 21055801 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2006, a primary completion of Jun 2009 and a completion of Jun 2009. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2010, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2007
First posted
Jan 12, 2007
Start
Dec 2006
Primary completionActual
Jun 2009
CompletionActual
Jun 2009
Results first posted
Sep 14, 2010
Last update
Jan 20, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00421733
Lead sponsor
Abbott
Responsible party
Sponsor
First posted
Jan 12, 2007
Start date
Dec 2006
Primary completion
Jun 2009
Completion
Jun 2009
Results posted
Sep 14, 2010
Last update
Jan 20, 2012

Study contacts

Dennis Andress, MD
study director · Abbott

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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