A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00389519
• Collaborator: (none)
• Enrollment: 422
• Locations: 101
• Arms: 4
• Duration (Months): 13
• Patients Per Site: 4.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The primary purpose of this study is to evaluate the blood pressure lowering effects of ramipril, an FDA-approved drug for the treatment of hypertension in adults, in children and adolescents aged 6 to 16 years with hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: ramipril; Drug: placebo	Phase 3

Detailed Description

Information is needed on the treatment of hypertension in children and adolescents with antihypertensive drugs like ramipril. The study will assess the safety and blood pressure effects of several doses of the antihypertensive drug ramipril in children and adolescents age 6-16 years. Approximately 450 children will be given placebo, or 1 of the 3 doses of ramipril. The treatment assigned will be done by chance, like flipping a coin. Approximately 120 study centers throughout the world will participate in the trial.

Each child will complete a 1- to 4-week Screening Period where they will stop taking their current blood pressure lowering drug(s), a 4-week Treatment Period where they will receive placebo or one of the ramipril doses, and a Follow-up visit 1 week after completion of the Treatment Period. Children diagnosed with hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (U.S. report), will be included in the study if their blood pressure meets certain values.

Each child will complete a minimum of 6 and up to 9 clinic visits over the course of the study during which procedures and assessments of blood pressure and safety will be performed. In addition, a child's parents/guardians will be instructed to measure their child's blood pressure at home between clinic visits.

A planned interim analysis was performed after approximately 240 subjects completed the trial. The study was stopped, as permitted by protocol, after the analysis.

Study Design

• Study Type: Interventional
• Actual Enrollment: 422 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Arm Study Assessing the Efficacy, Safety, and Dose-Response of Ramipril for the Treatment of Hypertension in Children and Adolescents
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Nov 1, 2007
• Actual Study Completion Date: Nov 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo once per day	Drug: placebo; once a day oral placebo capsule for 4 weeks
Experimental: ramipril low dose 0.3125, 0.625, or 1.25 mg once a day, based on subject weight	Drug: ramipril; once a day oral ramipril capsules given for 4 weeks; Other Names: Altace
Experimental: ramipril mid dose 1.25, 2.5, or 5 mg once a day, based on subject weight	Drug: ramipril; once a day oral ramipril capsules given for 4 weeks; Other Names: Altace
Experimental: ramipril high dose 5, 10, or 20 mg once a day, based on subject weight	Drug: ramipril; once a day oral ramipril capsules given for 4 weeks; Other Names: Altace

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure [Baseline to 4 weeks]

   Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo

Secondary Outcome Measures

1. Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure [Baseline to 4 weeks]

   Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo

2. Change From Baseline to 4 Weeks in Serum Creatinine [Baseline up to 4 weeks]

   Value at end of treatment (up to 4 weeks) minus value at baseline

3. Change From Baseline to 4 Weeks in Serum Potassium [Baseline up to 4 weeks]

   Value at end of treatment (up to 4 weeks) minus value at baseline

4. Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR) [Baseline up to 4 weeks]

   Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Previous, documented diagnosis of hypertension, or newly diagnosed hypertension according to the fourth report on the diagnosis, evaluation and treatment of high blood pressure in children and adolescents (United States). SiSBP greater than or equal to the 95th percentile for age, gender, and height.

2. The subject can be safely withdrawn from antihypertensive medications during the screening period, and if given placebo during the treatment period in the judgment of the Investigator.

3. The subject is male or female age 6 to 16 years (inclusive), and weighs greater than or equal to 20 kg.

4. Female subjects greater than or equal to 12 years of age, or who have had greater than or equal to 1 menstruation must: (a) have a negative serum pregnancy test at screening (i.e., subject is not pregnant), (b) not be lactating, and (c) use an acceptable method of contraception.

5. Parents/guardians are able to demonstrate their ability to (a) use a home blood pressure monitor supplied for the study to monitor their child's blood pressure, and (2) mix and administer a liquid dose of study drug if needed.

Exclusion Criteria:

1. Bilateral renal artery stenosis.

2. Uncorrected coarctation of the aorta or corrected coarctation with a right arm/right leg blood pressure gradient greater than 10 mmHg.

3. Severe hypertension.

4. Renal transplantation or other previous solid organ transplantation less than 6 months prior to entering the study.

5. Subjects with nephrotic syndrome not on stable maintenance therapy of prednisone or cyclosporine.

6. A history of cardiomyopathy, clinically significant structural heart disease, or atrioventricular conduction disturbance, sick sinus syndrome, atrial flutter, atrial fibrillation, clinically significant bradycardia or an accessory bypass tract, or clinical symptoms of congestive heart failure.

7. Clinically significant hematologic, hepatobiliary, or renal disease including a Schwartz formula GFR less than 40 mL/min/1.73 m2, and/or serum potassium (K+) greater than 5.5 mEq/L.

8. History of pancreatitis (active or inactive).

9. Known sensitivity to angiotensin converting enzyme inhibitors or a history of angioneurotic edema.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAMS College of Medicine/ Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
2	Woodland International Research Group, LLC	Little Rock	Arkansas	United States	72211
3	Impact Clinical Research	Beverly Hills	California	United States	90211
4	Neufeld Medical Group	Los Angeles	California	United States	90048
5	Almon Clinical Research, Inc.	Orange	California	United States	92868
6	Pediatrics in Brevard	Cocoa Beach	Florida	United States	33155
7	Watson Clinic Center for Research, Inc.	Lakeland	Florida	United States	33805
8	Emory University	Atlanta	Georgia	United States	30322
9	Medical College of Georgia	Augusta	Georgia	United States	30912
10	Hawaii Pacific Health	Honolulu	Hawaii	United States	96813
11	Nephrology and Hypertension Consultants	Park Ridge	Illinois	United States	60068
12	Tinley Park Pediatric Associates	Tinley Park	Illinois	United States	60477
13	Kosair Children's Hospital	Louisville	Kentucky	United States	40202
14	Louisiana State University	Shreveport	Louisiana	United States	71103
15	Craig Spiegel, MD	Bridgeton	Missouri	United States	63044
16	Impact Clinical Trials	Las Vegas	Nevada	United States	89106
17	Children's Heart Center	Las Vegas	Nevada	United States	89109
18	Premier Clinical Research Group	Toms River	New Jersey	United States	08755
19	SUNY Upstate Syracuse, Department of Pediatrics	Syracuse	New York	United States	13210
20	Hartrich Aquino & Hrab, PC	Williamsville	New York	United States	14221
21	Western Wake Pediatrics	Cary	North Carolina	United States	27518
22	University of North Carolina	Chapel Hill	North Carolina	United States	27514
23	Duke Pediatric Clinical Research Program	Durham	North Carolina	United States	27710
24	North Carolina Children's and Adults Clinical Research Foundation	Sylva	North Carolina	United States	28779
25	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
26	Center for Clinical and Translational Research	Columbus	Ohio	United States	43205
27	Central Sooner Research	Norman	Oklahoma	United States	73069
28	The University of Oklahoma	Tulsa	Oklahoma	United States	74135
29	Oregon Health and Science University	Portland	Oregon	United States	97201
30	Northwest Pediatric Kidney Specialists, LLC	Portland	Oregon	United States	97227
31	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
32	Holston Medical Group	Kingsport	Tennessee	United States	37660
33	Le Bonheur Children's Hospital	Memphis	Tennessee	United States	38105
34	South East Texas Cardiology Associates	Beaumont	Texas	United States	77701
35	University of Texas Medical Center	Houston	Texas	United States	77030
36	University of Utah	Salt Lake City	Utah	United States	84108
37	University of Virginia	Charlottesville	Virginia	United States	22908
38	Huguenot Pediatrics	Midlothian	Virginia	United States	23113
39	Children's Specialty Group	Norfolk	Virginia	United States	23510
40	Hospital de Niños "Dr. Ricardo Gutiérrez"	Buenos Aires		Argentina
41	Hospital General Interzonal "Dr. José Penna"	Buenos Aires		Argentina
42	Hospital Interzonal Especializado Materno Infantil	Buenos Aires		Argentina
43	Hospital Italiano de Buenos Aires	Buenos Aires		Argentina
44	Hospital de Niños Juan Carlos Navarro	San Juan		Argentina
45	Centro Infantil del Rínon	Tucomán		Argentina
46	Clínica Las Condes	Santiago		Chile
47	Hospital de Niños Roberto del Rio	Santiago		Chile
48	Hospital Luis Calvo Mackena	Santiago		Chile
49	Hospital Dr. Gustavo Fricke	Vina del Mar		Chile
50	Fundación Bios	Barranquilla		Colombia
51	Fundación Cardio Infantil - Instituto de Cardiología	Bogotá		Colombia
52	Hospital de San Jose	Bogotá		Colombia
53	Instituto Nacional del Riñón	Bogotá		Colombia
54	Hospital Pablo Tobon Uribe	Medellin		Colombia
55	Hospital Universitario San Vicente de Paul	Medellin		Colombia
56	Hospital Pablo Tobon Uribe	Medellín		Colombia
57	Gujarat Kidney Foundation, Jivraj Mehta Hospital	Ahmedabad		India
58	Heart Care Clinic	Ahmedabad		India
59	St. John's Hospital	Bangalore		India
60	Institute of Child Health & Hospital for Children	Chennai		India
61	AIl India Institute medical sciences	Delhi		India
62	Apollo Hospital	Delhi		India
63	Maulana Azad Medical College and Lok Nayak Hospital	Delhi		India
64	Apollo Hospital Hyderabad	Hyderabaad		India
65	Nizam's Institute of Medical Sciences	Hyderabaad		India
66	Christian Medical College and Hospital	Ludhiana		India
67	Jaslok Hospital and Research Centre	Mumbai		India
68	KEM Hospital Research Centre	Pune		India
69	Kerala Institute of Medical Science	Trivandrum		India
70	Klinika Nefrologii Dzieciecej SPSK nr 1 ACK AMG	Gdansk		Poland
71	Katedra i Klinika Kardiologii Dzieciecej SK nr 6, Gornoslaskie Centrum Zdrowia Dziecka i Matki, Slaska AM	Katowice		Poland
72	II Katedra Pediatrii, Klinika Kardiologii Dzieciecej UM w Lodzi	Lodz		Poland
73	Klinika Nefrologii i Dializoterapii, Instytut Centrum Zdrowia Matki Polki	Lodz		Poland
74	Klinika Kardiologii i Nefrologii Dzieciecej AM	Poznan		Poland
75	I Klinika Chorob Dzieci SPSK nr 1 PAM	Szczecin		Poland
76	Oddzial Nefrologi Dzieciecej ze Stacja Dializ SSP ZOZ nad Dziecklem i Mlodzieza	Szczecin		Poland
77	Oddzial Pediatrii i Nefrologii ze Stacja Dializ, Wojewodzki Szpital Dzieciecy	Torun		Poland
78	Klinika Nefrologii i Transplantacji Nerek, Instytut Pomnik Centrum Zdrowia Dziecka	Warszawa		Poland
79	Klinika Nefrologii Pediatrycznej AM	Wroclaw		Poland
80	Benmed Park Clinic	Benoni		South Africa
81	Chris Hani Baragwanath	Johannesburg		South Africa
82	Global Clinical Trial Centre	Port Elizabeth		South Africa
83	Potchefstroom Medi-Clinic	Potchefstroom		South Africa
84	Eastmed Medical centre	Pretoria		South Africa
85	Jubilee CTC Jubilee Hospital	Pretoria		South Africa
86	Pretoria Academic Hospital	Pretoria		South Africa
87	Zuid Afrikaans Hospital	Pretoria		South Africa
88	Sandton Clinical Research Centre	Sandton		South Africa
89	Istanbul University Istanbul Medical Faculty Pediatric Nephrology	Istanbul		Turkey
90	Marmara University Medical Faculty Pediatric Nephrology	Istanbul		Turkey
91	Dokuzeylul University Medical Faculty Pediatric Nephrology	Izmir		Turkey
92	Ondokummayis University Medical Faculty Pediatric Nephrology	Samsun		Turkey
93	Dnepropetrovsk Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital	Dnepropetrovsk		Ukraine
94	Kharkov State University,Dept. of hospital pediatric on the bases of Regional Children's Hospital	Kharkov		Ukraine
95	NMU n.b. Bogomolets, on b.o. Chil. Clin.Hosp.#2, Department of Pediatrics #2	Kiev		Ukraine
96	Institute of Pediatrics and Obstetrics AMS of Ukraine, Department of ecology related health problems	Kyiv		Ukraine
97	Danylo Halytskiy Lviv NationalMedical University, Department of Faculty	Lviv		Ukraine
98	Odessa State Medical University, Dept. of hospital pediatric and neonotology on the bases of Regional Children Hospital	Odessa		Ukraine
99	Crim.St. Med. Uni. On b.o. Rep. Child.Clin.Hosp. Chair of Pediat. W.c. of Physioth. Of the Postgr.dept	Simferopol		Ukraine
100	Uzhorod National University, Medical faculty, Department of Children's disease with course of Infection disease on the basis of City Children's Clinical Hospital.	Uzhorod		Ukraine
101	Vinnitsa National Medical Academy, Department of Hospital Pediatrics on the bases of Regional Pediatric Hospital	Vinnitsa		Ukraine

Sponsors and Collaborators

• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00389519
• Other Study ID Numbers: K726-06-4003
• First Posted: Oct 19, 2006
• Last Update Posted: Jun 11, 2012
• Last Verified: Jun 1, 2012

• Keywords provided by , ,: Hypertension/*etiology; Blood Pressure; Pediatric; Adolescent; Child
• Additional relevant MeSH terms: Hypertension; Ramipril

Study Results

Participant Flow

Recruitment Details	Study was conducted from October 2006 to November 2007 at 56 international sites
Pre-assignment Detail	Subjects entered placebo run-in prior to randomization

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
Arm/Group Description
Period Title: Placebo Run-In
STARTED	422	0	0	0
COMPLETED	244	0	0	0
NOT COMPLETED	178	0	0	0
Period Title: Placebo Run-In
STARTED	83	41	40	80
COMPLETED	81	41	40	80
NOT COMPLETED	2	0	0	0
Period Title: Placebo Run-In
STARTED	81	41	40	80
COMPLETED	79	40	40	76
NOT COMPLETED	2	1	0	4

Baseline Characteristics

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	81	41	40	80	242
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.2 (3.06)	12.3 (3.03)	12.1 (2.81)	12.3 (3.06)	12.2 (2.99)
Sex: Female, Male (Count of Participants)
Female	32 39.5%	16 39%	11 27.5%	29 36.3%	88 36.4%
Male	49 60.5%	25 61%	29 72.5%	51 63.8%	154 63.6%
Race/Ethnicity, Customized (participants) [Number]
Black	21 25.9%	11 26.8%	10 25%	20 25%	62 25.6%
Asian	8 9.9%	1 2.4%	4 10%	10 12.5%	23 9.5%
Caucasian	27 33.3%	15 36.6%	13 32.5%	29 36.3%	84 34.7%
Hispanic	25 30.9%	14 34.1%	13 32.5%	20 25%	72 29.8%
Other	0 0%	0 0%	0 0%	1 1.3%	1 0.4%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure
Description	Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
Arm/Group Description
Measure Participants	80	41	40	80
Mean (Standard Deviation) [mm Hg]	-8.1 (7.92)	-9.7 (10.68)	-11.1 (8.88)	-11.3 (8.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ramipril High Dose
	Comments	Planned interim efficacy analysis: 80 placebo and 80 high-dose ramipril subjects provided 93% power, alpha=0.032, to detect 5 mmHg difference in primary outcome. SD of 8.5 mmHg assumed. Alpha of 0.032 required for the planned interim efficacy analysis. If study continued: 450 total subjects would provide 90% power, alpha=0.027, to detect 3 mmHg difference between placebo and combined ramipril dose groups. Alpha of 0.027 required for the final analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments	two-sided test
	Method	ANCOVA
	Comments	test from contrast statement from full model

2. Secondary Outcome

Title	Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure
Description	Value at end of treatment minus value at baseline, comparing the high-dose ramipril group with placebo
Time Frame	Baseline to 4 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) analysis including only treated participants who had at least one post-baseline assessment (1 placebo patient was treated but had no post-baseline assessment); last observation carried forward (LOCF)

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
Arm/Group Description
Measure Participants	80	41	40	80
Mean (Standard Deviation) [mm Hg]	-5.0 (10.04)	-5.8 (10.17)	-6.1 (8.03)	-8.4 (9.14)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Ramipril High Dose
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments	two-sided, unadjusted
	Method	ANCOVA
	Comments	test from contrast statement from full model

3. Secondary Outcome

Title	Change From Baseline to 4 Weeks in Serum Creatinine
Description	Value at end of treatment (up to 4 weeks) minus value at baseline
Time Frame	Baseline up to 4 weeks

Outcome Measure Data

Analysis Population Description

Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
Arm/Group Description
Measure Participants	78	39	38	77
Mean (Standard Deviation) [mg/dL]	0.04 (0.305)	0.06 (0.275)	0.03 (0.133)	0.06 (0.211)

4. Secondary Outcome

Title	Change From Baseline to 4 Weeks in Serum Potassium
Description	Value at end of treatment (up to 4 weeks) minus value at baseline
Time Frame	Baseline up to 4 weeks

Outcome Measure Data

Analysis Population Description

Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
Arm/Group Description
Measure Participants	79	39	40	77
Mean (Standard Deviation) [mg/dL]	0.01 (0.742)	-0.20 (0.475)	-0.08 (0.418)	0.07 (0.559)

5. Secondary Outcome

Title	Change From Baseline to 4 Weeks in Schwartz Formula Glomerular Filtration Rate (GFR)
Description	Value at end of treatment (up to 4 weeks) minus value at baseline; GFR is a measure of kidney function.
Time Frame	Baseline up to 4 weeks

Outcome Measure Data

Analysis Population Description

Number of participants analyzed is less than number treated in the participant flow section because analysis includes only treated participants who had both a baseline and a post-baseline assessment; LOCF

Arm/Group Title	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
Arm/Group Description
Measure Participants	78	39	38	77
Mean (Standard Deviation) [mL/min per 1.73 m2]	-4.2 (27.85)	-6.0 (24.74)	-5.9 (26.29)	-6.9 (30.58)

Adverse Events

Arm/Group Title	Placebo		Ramipril Low Dose		Ramipril Mid Dose		Ramipril High Dose
Arm/Group Description
All Cause Mortality
	Placebo		Ramipril Low Dose		Ramipril Mid Dose		Ramipril High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Ramipril Low Dose		Ramipril Mid Dose		Ramipril High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/81 (0%)		1/41 (2.4%)		1/40 (2.5%)		0/80 (0%)
Infections and infestations
pyelonephritis	0/81 (0%)		1/41 (2.4%)		0/40 (0%)		0/80 (0%)
Renal and urinary disorders
nephrotic syndrome	0/81 (0%)		0/41 (0%)		1/40 (2.5%)		0/80 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Ramipril Low Dose		Ramipril Mid Dose		Ramipril High Dose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/81 (13.6%)		8/41 (19.5%)		6/40 (15%)		12/80 (15%)
Gastrointestinal disorders
abdominal pain upper	2/81 (2.5%)		0/41 (0%)		3/40 (7.5%)		1/80 (1.3%)
General disorders
chest pain	0/81 (0%)		0/41 (0%)		3/40 (7.5%)		0/80 (0%)
Infections and infestations
upper respiratory tract infection	2/81 (2.5%)		4/41 (9.8%)		1/40 (2.5%)		1/80 (1.3%)
Nervous system disorders
dizziness	2/81 (2.5%)		0/41 (0%)		2/40 (5%)		2/80 (2.5%)
headache	6/81 (7.4%)		4/41 (9.8%)		3/40 (7.5%)		8/80 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigator agreed not to individually publish results of the study. Investigators may participate in a joint multicenter publication of the study results. Written notice must be provided to King. King has the right to review the publication and can require deletion of Confidential Information and delay of publication to allow for filing of patent applications.