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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00196989

Registration number

NCT00196989

Ethics application status

Date submitted

13/09/2005

Date registered

20/09/2005

Titles & IDs

Public title

Study In People With Type 2 Diabetes

Scientific title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of Oral GW677954 as a Monotherapy for 12 Weeks Duration in Patients With Type 2 Diabetes Mellitus

Secondary ID [1]

ADG20001

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes Mellitus, Type 2

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Percentage change from Baseline (Day 1) in glycated hemoglobin (HbA1c) levels at Week 16 as a measure of improvement in glucose control

Assessment method [1]

Improvement in glucose control was measured by means of reduction in glycated hemoglobin (Hb) levels in blood.

Timepoint [1]

Week (W) 16

Secondary outcome [1]

Percentage change from Baseline (Day 1) in fasting HbA1c levels at Weeks 4, 8 and 12

Assessment method [1]

Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [1]

Weeks 4, 8, and 12

Secondary outcome [2]

Change from Baseline (Day 1) in fasting plasma glucose (FPG) at Weeks 1, 2, 4, 6, 8, 12 and 16

Assessment method [2]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [2]

W1, W2, W4, W6, W8, W12, and W16

Secondary outcome [3]

Change from Baseline (Day 1) in fasting fructosamine at Weeks 2 and 4

Assessment method [3]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [3]

Baseline (Day 1), W2, W4

Secondary outcome [4]

Percentage of participants achieving target HbA1c levels at Weeks 4, 8, 12, and 16

Assessment method [4]

Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood. The ideal concentration of HbA1c was desired to be less than or equal to 7%.

Timepoint [4]

Weeks 4, 8, 12, and 16

Secondary outcome [5]

Percentage of participants achieving a decrease in HbA1c of >= 0.7% from Baseline (Day 1) at Weeks 4, 8, 12 and 16

Assessment method [5]

Improvement in glucose control was measured by means of reduction in glycated hemoglobin (HbA1c) levels in blood.

Timepoint [5]

Baseline (Day 1), Weeks 4, 8, 12, and 16

Secondary outcome [6]

Percentage of participants achieving target range of FPG at Weeks 1, 2, 4, 6, 8, 12 and 16

Assessment method [6]

The target range for FPG was \<=126 milligrams per deciliter (mg/dL) or 7.0 millimoles per liter (mmol/L) to \<=140 mg/dL or 7.8 mmol/L

Timepoint [6]

Weeks 1,2, 4, 6, 8, 12, and 16

Secondary outcome [7]

Percentage of participants achieving a decrease from Baseline (Day 1) of >=30 mg/dL [1.66 mmol/L] in FPG at Weeks 1, 2, 4, 6, 8, 12 and 16

Assessment method [7]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [7]

Weeks 1, 2, 4, 6, 8, 12, and 16

Secondary outcome [8]

Ratio to the Baseline (percentage change) of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and free fatty acids (FFA) at Weeks 2, 4, 8, 12, and 16

Assessment method [8]

This data analysis was based on log-transformed data.

Timepoint [8]

Baseline (Day 1), Weeks 2, 4, 8, 12, and 16

Secondary outcome [9]

Percentage change from Baseline (Day 1) in non-HDL-C based on log-transformed data at Week 16

Assessment method [9]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [9]

At Week 16

Secondary outcome [10]

Percentage change from Baseline (Day 1) in very low density lipoprotein-cholesterol (VLDL-C), apolipoprotein AI (Apo AI), AII, and B at Week 16.

Assessment method [10]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [10]

At Week 16

Secondary outcome [11]

Change from Baseline (Day 1) in Apo B/TC, TC/HDL-C, and LDL-C/Apo B ratio at Week 16

Assessment method [11]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [11]

At Week 16

Secondary outcome [12]

Change from Baseline (Day 1) in hemoglobin at Week 16

Assessment method [12]

This analysis was performed in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [12]

At Week 16

Secondary outcome [13]

Change from Baseline (Day 1) in hematocrit at Week 16

Assessment method [13]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [13]

Wekk 16

Secondary outcome [14]

Change from Baseline (Day 1) in systolic and diastolic blood pressure (SBP and DBP) at Week 16

Assessment method [14]

Systolic blood pressure )SBP) and diastolic blood pressure (DBP) were measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [14]

At Week 16

Secondary outcome [15]

Change from Baseline (Day 1) in heart rate at Week 16

Assessment method [15]

Heart rate was measured in sitting position. Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [15]

Week 16

Secondary outcome [16]

Change from Baseline (Day 1) in body weight at Week 16

Assessment method [16]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [16]

Week 16

Secondary outcome [17]

Change from Baseline (Day 1) in 12 lead electrocardiogram (ECG) measures including PR interval, QT interval, QTc interval and QRS duration at Week 16

Assessment method [17]

QT(c) interval calculations were done by Bazett's method (QTc\[B\]) as well as by Fridericia's correction (QTc\[F\]). Change from Baseline is the value at indicated time point minus the Baseline value.

Timepoint [17]

Week 16

Secondary outcome [18]

Number of participants with clinical hematology, chemistry, urinalysis, exploratory cardiac parameters of potential clinical concern (PCC) along with serum pregnancy test over period

Assessment method [18]

Participants were analyzed for any abnormality for laboratory parameters either higher or lower than the potential clinical concern range.

Timepoint [18]

Upto 16 weeks

Secondary outcome [19]

Number of participants with hypoglycemic events as a measure of ophthalmic assessment

Assessment method [19]

Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis.

Timepoint [19]

Up to 16 weeks

Secondary outcome [20]

Number of participants with intensity of hypoglycemic events as a measure of ophthalmic assessment

Assessment method [20]

Participants received a glucose log for reading for routine recording of glucometer readings. Glucose values were recorded on timely basis.

Timepoint [20]

Up to 16 weeks

Secondary outcome [21]

Number of participants with adverse events (AEs) and serious adverse events (SAEs) over period

Assessment method [21]

Adverse event (AE) is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. Serious adverse event (SAE) is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

Timepoint [21]

Up to 16 weeks

Secondary outcome [22]

Change from Baseline (Day 1) in phosphocreatine kinase (Creatine kinase-MB) over period

Assessment method [22]

CK-MB is a cardiac biomarker.

Timepoint [22]

Up to 16 weeks

Secondary outcome [23]

Number of participants with absolute Troponin-I (cTnI) levels over period

Assessment method [23]

Troponin-I (cTnI) is a cardiac biomarker.

Timepoint [23]

Up to 16 weeks

Secondary outcome [24]

Change from Baseline (Day 1) in fasting insulin at Week 8 and 16

Assessment method [24]

Change from Baseline is the value at indicated time point minus the value at Baseline.

Timepoint [24]

Week 8 and 16

Secondary outcome [25]

Change from Baseline (Day 1) in C-peptide at Week 8 and 16

Assessment method [25]

Timepoint [25]

Week 8 and 16

Secondary outcome [26]

Change from Baseline (Day 1) in HOMA-S at Week 16

Assessment method [26]

Timepoint [26]

Week 16

Secondary outcome [27]

Change from Baseline (Day 1) in QUICKI at Week 16

Assessment method [27]

Timepoint [27]

Week 16

Eligibility

Key inclusion criteria

Inclusion criteria:

* Subjects with T2DM as defined by the criteria of the ADA and/or recognized by WHO Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004], for at least 3 months preceding screening (see Section 15.3, Appendix 3:, "Diagnosis and Classification of Diabetes Mellitus").
* To be eligible for Randomization into the trial, a subject must satisfy all of the following glycemic criteria:

* HbA1c level via central laboratory at the pre-screening visit
* If HbA1c = 8.0% but = 10.0%: subject may proceed to Randomization;
* If HbA1c = 7.8% but < 8.0%, subject not eligible to proceed, but may be retested once to establish eligibility (or lack thereof). If HbA1c level = 8.0% upon retest, subject is eligible to proceed; otherwise they should be withdrawn.
* If HbA1c < 7.8%, subject not eligible to proceed (no retest allowed).
* FPG level via central laboratory at the pre-screening visit must be < 270 mg/dL (15.0 mmol/L). FPG may be retested within a week to confirm eligibility (or lack thereof).
* Concurrent T2DM therapy:

* Diet and/or exercise treated: Must not have taken antidiabetic medication for at least 2 months prior to the pre-screening visit, OR
* Metformin monotherapy: Subjects entering the study on metformin must be on the same dose, formulation and regimen of metformin for at least 2 months prior to the pre-screening visit, AND
* TZDs and insulin are excluded in the 3 months prior to the Screening visit for all subjects.
* Males and females who are 18 to 70 years of age inclusive at the time of Screening.
* If female, eligible to enter and participate in this study:

* If of non-childbearing potential (i.e., physiologically incapable of becoming pregnant (tubal ligation), including any female who is post-menopausal [>1 year without menstrual period]); or,
* If of child-bearing potential, has a negative pregnancy test at Screening (serum), at Randomization (urine) and:

* Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or
* Uses double-barrier methods of contraception; condoms with the use of caps (with spermicide) and IUDs are acceptable, or
* Uses hormonal contraceptives (oral, depots, patches etc) with double- barrier methods of contraception as outlined above, or
* Abstains from sexual intercourse, or
* Is with a same sex partner and does not participate in bisexual activities where there is any risk of pregnancy.
* Body Mass Index (BMI): =25 and =40 kg/m² and weigh at least 50 kg at Screening.
* If subject is a smoker, must be able to abstain while in clinic at each visit.
* Subject has given full written informed consent prior to any study related procedures are performed.

Minimum age

18 Years

Maximum age

70 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria:

* Metabolic Disease including:

* Diagnosis of Type 1 diabetes mellitus
* Uncorrected thyroid dysfunction. (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least 1 month prior to Screening, and who have a screening thyroid stimulating hormone (TSH) within the upper limit of normal may participate).
* Significant weight gain or loss (defined as > 5% of total body weight) within the 3 months prior to Screening.
* Previous use of insulin for treatment of hyperglycemia within 3 months of Screening.
* History of recent clinically significant cardiovascular disease including:

* History or ECG evidence of prior myocardial infarction within 6 months prior to Screening.
* Current unstable angina or history of unstable angina in past 6 months.
* Coronary revascularization including percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery that is either planned or occurred in the 6 months prior to Screening.
* Clinically significant arrhythmia or valvular heart disease.
* Congestive heart failure (CHF) with New York Heart Association (NYHA) Class II-IV symptoms (see Section 15.4, Appendix 4).
* Blood pressure > 160/100 mmHg or resting heart rate > 100 bpm. Note: subjects using antihypertensives [e.g., beta blockers, angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers and diuretics] must be on stable doses during the 30 days prior to Screening and during the trial.
* Has a QTc interval (Bazett's) > 440 msec in males and > 450 msec in females at Screening.
* Clinically significant ECG abnormalities which, in the opinion of the Investigator, may affect the interpretation of safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity.
* History of chronic pancreatitis.
* Familial hypercholesterolemia.
* TGs =800 mg/dL (8.96 mmol/L) at Screening.
* Serum creatinine at screening > 1.4 mg/dL (124 µmol/L) for women, or > 1.5 mg/dL (133 µmol/L) for men.
* Clinically significant anemia defined by hemoglobin concentrations <12.0 g/dL or < 120.0 g/L for males and < 11.0 g/dL or < 110.0 g/L for females.
* History of significant co-morbid diseases (e.g., cholelithiasis, gastrointestinal disease, etc.) that would preclude participation in the study.
* Documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody) at Screening, and/or clinically significant hepatic enzyme elevation including:

•Any one of the following enzymes greater than 2.5 times the upper limit of normal (ULN) value at Screening:
* Alanine aminotransferase (ALT)
* Aspartate aminotransferase (AST)
* Alkaline phosphatase (ALP)
* Total or direct bilirubin > 1.5 times the ULN at Screening, unless consistent with presumed or diagnosed Gilbert's disease.
* History of metabolic acidosis, rhabdomyolysis, myalgia, myositis or myopathy after taking statins or fibrates.
* Any subject who has withdrawn therapy due to AEs after taking a PPAR? or a PPARa/? dual agonist, either marketed (e.g., troglitazone, rosiglitazone or pioglitazone) or under current or previous clinical investigation.
* Signs or symptoms of myositis at Screening (or upon 1 repeat test), and/or creatinine phosphokinase (CPK)=3.0 times ULN
* Is currently taking or has taken any of the following medications in the 3 months prior to the pre-screening visit:

* Anti-obesity agents (including fat absorption blocking agents)
* St. John's Wort
* Warfarin and other oral anticoagulants (excluding aspirin and non-steroidal anti-inflammatory drugs)
* Digoxin
* Oral or injectable corticosteroids (inhaled and intranasal steroids are acceptable)
* Use of antidiabetic agents (other than metformin) in the 2 months prior to the pre-screening visit.
* Use of TZDs in the 3 months prior to the pre-screening visit.
* Methotrexate, cyclosporine or monoclonal antibodies (e.g., alemtuzumab, gemtuzumab ozogamicin, rituximab, trastuzumab, ibritumomab, tiuxetan) for rheumatoid arthritis or psoriasis.
* Atypical antipsychotic medications [e.g., aripiprazole (Abilify), risperidone (Risperdal), clozapine (Clozaril), olanzapine (Zyprexa), quetiapine (Seroquel), and ziprasidone (Geodon)].
* Antiretroviral drugs
* Use of lipid lowering agents within 3 months prior to the pre-screening visit. This includes statins, fibrates, ezetimibe (Zetia), niacin and bile acid sequestrants.
* Monoamine oxidase inhibitors
* History of cancer except for the following:

* Basal cell carcinoma or superficial squamous cell carcinoma treated by local excision.
* Cervical cancer in situ treated definitively more than 6 months prior to screening.
* Women who are lactating, pregnant, or planning to become pregnant.
* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to any drug chemically related to the study drug.
* Known allergy to any of the capsule excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation. Hypersensitivity to metformin or any of its components (for subjects entering on metformin).
* Has a history of substance and/or alcohol abuse within the past year as determined by the Investigator at screening or during treatment:

* Unwilling to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.
* History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.
* Received treatment with a new molecular entity (investigational drug) during the previous 4 months or participated in any other trial during the previous 3 months, or has participated in a previous study with GW677954. A new molecular entity is defined as any compound not in Phase 3. (The washout is from last dose of investigational product in the previous study until the first dose of investigational product.)
* Likely to be non-compliant, in the investigator's opinion, with respect to the protocol and related scheduled visits.
* Subject has any concomitant medical condition which in the opinion of the investigator makes them unsuitable to participate in the study.
* Subject is either an immediate family member of a participating investigator, study coordinator, employee of an investigator; or is a member of the staff conducting the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/09/2005

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/04/2007

Sample size

Target

Accrual to date

Final

448

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Recruitment hospital [1]

GSK Investigational Site - Miranda

Recruitment hospital [2]

GSK Investigational Site - Carina Heights

Recruitment hospital [3]

GSK Investigational Site - Spring Hill

Recruitment hospital [4]

GSK Investigational Site - Adelaide

Recruitment hospital [5]

GSK Investigational Site - Keswick

Recruitment hospital [6]

GSK Investigational Site - Port Lincoln

Recruitment hospital [7]

GSK Investigational Site - Box Hill

Recruitment hospital [8]

GSK Investigational Site - Ringwood East

Recruitment postcode(s) [1]

2228 - Miranda

Recruitment postcode(s) [2]

4152 - Carina Heights

Recruitment postcode(s) [3]

4000 - Spring Hill

Recruitment postcode(s) [4]

5000 - Adelaide

Recruitment postcode(s) [5]

5035 - Keswick

Recruitment postcode(s) [6]

5606 - Port Lincoln

Recruitment postcode(s) [7]

3128 - Box Hill

Recruitment postcode(s) [8]

3135 - Ringwood East

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Alabama

Country [2]

United States of America

State/province [2]

Arizona

Country [3]

United States of America

State/province [3]

California

Country [4]

United States of America

State/province [4]

Colorado

Country [5]

United States of America

State/province [5]

Connecticut

Country [6]

United States of America

State/province [6]

Florida

Country [7]

United States of America

State/province [7]

Georgia

Country [8]

United States of America

State/province [8]

Hawaii

Country [9]

United States of America

State/province [9]

Illinois

Country [10]

United States of America

State/province [10]

Indiana

Country [11]

United States of America

State/province [11]

Massachusetts

Country [12]

United States of America

State/province [12]

Missouri

Country [13]

United States of America

State/province [13]

Nevada

Country [14]

United States of America

State/province [14]

New Mexico

Country [15]

United States of America

State/province [15]

New York

Country [16]

United States of America

State/province [16]

North Carolina

Country [17]

United States of America

State/province [17]

Ohio

Country [18]

United States of America

State/province [18]

Pennsylvania

Country [19]

United States of America

State/province [19]

Rhode Island

Country [20]

United States of America

State/province [20]

South Carolina

Country [21]

United States of America

State/province [21]

Tennessee

Country [22]

United States of America

State/province [22]

Texas

Country [23]

United States of America

State/province [23]

Utah

Country [24]

United States of America

State/province [24]

Virginia

Country [25]

United States of America

State/province [25]

Washington

Country [26]

United States of America

State/province [26]

Wisconsin

Country [27]

Argentina

State/province [27]

Buenos Aires

Country [28]

Argentina

State/province [28]

Córdova

Country [29]

Argentina

State/province [29]

San Juan

Country [30]

Canada

State/province [30]

British Columbia

Country [31]

Canada

State/province [31]

Manitoba

Country [32]

Canada

State/province [32]

Newfoundland and Labrador

Country [33]

Canada

State/province [33]

Nova Scotia

Country [34]

Canada

State/province [34]

Ontario

Country [35]

Canada

State/province [35]

Quebec

Country [36]

Colombia

State/province [36]

Bogotá

Country [37]

Costa Rica

State/province [37]

San José

Country [38]

Czech Republic

State/province [38]

Ceske Budejovice

Country [39]

Czech Republic

State/province [39]

Cheb

Country [40]

Czech Republic

State/province [40]

Olomouc

Country [41]

Czech Republic

State/province [41]

Praha 10

Country [42]

Czech Republic

State/province [42]

Praha 2

Country [43]

Czech Republic

State/province [43]

Praha 5

Country [44]

Ecuador

State/province [44]

Quito

Country [45]

Latvia

State/province [45]

Cesis

Country [46]

Latvia

State/province [46]

Daugavpils

Country [47]

Latvia

State/province [47]

Riga

Country [48]

Latvia

State/province [48]

Tukums

Country [49]

Mexico

State/province [49]

Baja California Norte

Country [50]

Mexico

State/province [50]

Hidalgo

Country [51]

Mexico

State/province [51]

Morelos

Country [52]

Mexico

State/province [52]

Nuevo León

Country [53]

Mexico

State/province [53]

Durango

Country [54]

Mexico

State/province [54]

Mexico, D.F.

Country [55]

New Zealand

State/province [55]

Auckland

Country [56]

New Zealand

State/province [56]

Christchurch

Country [57]

New Zealand

State/province [57]

Rotorua

Country [58]

New Zealand

State/province [58]

Tauranga

Country [59]

Peru

State/province [59]

Lima

Country [60]

Russian Federation

State/province [60]

Moscow

Country [61]

Russian Federation

State/province [61]

Perm

Country [62]

Russian Federation

State/province [62]

Samara

Country [63]

Russian Federation

State/province [63]

Tumen

Country [64]

Russian Federation

State/province [64]

Ufa

Country [65]

Russian Federation

State/province [65]

Yaroslavl

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

GlaxoSmithKline

Country

Ethics approval

Ethics application status

Summary

Brief summary

This Phase 2 dose-ranging study will evaluate the efficacy, safety and tolerability of a range of doses of GW677954 compared with placebo over sixteen weeks of treatment in subjects with T2DM (Type 2 Diabetes Mellitus).

Trial website

https://clinicaltrials.gov/study/NCT00196989

Public notes

Contacts

Principal investigator

Name

GSK Clinical Trials

Address

GlaxoSmithKline

Country

Phone

Contact person for public queries

Name

Address

Country

Phone

Contact person for scientific queries

Data sharing statement

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00196989

Register a trial

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00196989