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

This study has been terminated.

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

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00389519

First received: October 17, 2006

Last updated: June 6, 2012

Last verified: June 2012

History of Changes

Results First Received: January 21, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: ramipril Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study was conducted from October 2006 to November 2007 at 56 international sites

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects entered placebo run-in prior to randomization

Reporting Groups

	Description
Placebo	No text entered.
Ramipril Low Dose	No text entered.
Ramipril Mid Dose	No text entered.
Ramipril High Dose	No text entered.

Participant Flow for 3 periods

Period 1: Placebo Run-In

	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
STARTED	422	0	0	0
COMPLETED	244	0	0	0
NOT COMPLETED	178	0	0	0
Did not meet blood pressure criteria	119	0	0	0
Withdrawal by Subject	19	0	0	0
Reason not specified	40	0	0	0

Period 2: Randomized

	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
STARTED	83	41	40	80
COMPLETED	81	41	40	80
NOT COMPLETED	2	0	0	0
Did not receive study drug	2	0	0	0

Period 3: Treated

	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose
STARTED	81	41	40	80
COMPLETED	79	40	40	76
NOT COMPLETED	2	1	0	4
Adverse Event	1	0	0	2
Reason not specified	1	1	0	2

Baseline Characteristics

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Reporting Groups

	Description
Placebo	No text entered.
Ramipril Low Dose	No text entered.
Ramipril Mid Dose	No text entered.
Ramipril High Dose	No text entered.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Ramipril Low Dose	Ramipril Mid Dose	Ramipril High Dose	Total
Number of Participants [units: participants]	81	41	40	80	242
Age [units: years] Mean ± Standard Deviation	12.2 ± 3.06	12.3 ± 3.03	12.1 ± 2.81	12.3 ± 3.06	12.2 ± 2.99
Gender [units: participants]
Female	32	16	11	29	88
Male	49	25	29	51	154
Race/Ethnicity, Customized [units: participants]
Black	21	11	10	20	62
Asian	8	1	4	10	23
Caucasian	27	15	13	29	84
Hispanic	25	14	13	20	72
Other	0	0	0	1	1

Outcome Measures

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1. Primary:

Change From Baseline to 4 Weeks in Trough Sitting Systolic Blood Pressure [ Time Frame: Baseline to 4 weeks ]

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2. Secondary:

Change From Baseline to 4 Weeks in Trough Sitting Diastolic Blood Pressure [ Time Frame: Baseline to 4 weeks ]

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3. Secondary:

Change From Baseline to 4 Weeks in Serum Creatinine [ Time Frame: Baseline up to 4 weeks ]

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4. Secondary:

Change From Baseline to 4 Weeks in Serum Potassium [ Time Frame: Baseline up to 4 weeks ]

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5. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Professional Information Services
Organization: King Pharmaceuticals, Inc.
phone: 1-800-776-3637

No publications provided

ClinicalTrials.gov Identifier:	NCT00389519 History of Changes
Other Study ID Numbers:	K726-06-4003
Study First Received:	October 17, 2006
Results First Received:	January 21, 2010
Last Updated:	June 6, 2012
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: Ministry of Health Canada: Health Canada Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos India: Ministry of Health Poland: Ministry of Health South Africa: Medicines Control Council Turkey: Ministry of Health Ukraine: Ministry of Health

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