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Adult Trials: 18+ Years
- Males or females age 6 to 16 years. All female subjects ≥ 8 years of age must have a negative urine pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.
- Weight ≥ 20 kg.
- Parents/guardians must be able to demonstrate their ability to use the home blood pressure device to monitor blood pressure.
- Sitting systolic blood pressure or sitting diastolic blood pressure ≥ the 95th percentile for age, gender and height; or diabetes mellitus or chronic renal insufficiency (as evidenced by GFR 40-70 mL/min/1.73 m2) and a sitting systolic blood pressure or sitting diastolic blood pressure ≥ the 90th percentile for age, gender, and height.
- Severe hypertension documented by (1) Sitting systolic blood pressure or sitting
diastolic blood pressure more than 20 mmHg above the 95th percentile for age, gender,
and height without antihypertensive therapy, (2) Sitting systolic blood pressure or
sitting diastolic blood pressure more than 12 mmHg above the 95th percentile for age,
gender, and height while receiving active therapy, or (3) hypertensive encephalopathy
within the previous 5 months.
- Currently receiving more than one antihypertensive medication including: ACE
inhibitors, angiotensin receptor inhibitors, beta blockers, calcium channel blockers,
diuretics.
- Receiving lithium, potassium supplements, monoamine oxidase inhibitors, or major
tranquilizers (Note: Stimulant medications for behavioral disorders, corticosteroids,
and non-steroidal anti-inflammatory agents for chronic pain management are permitted
during the trial provided the subject's dosage is anticipated to remain unchanged
throughout the duration of the study.)
- 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.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Treatment of Pediatric Hypertension With Altace Trial | ||
| Official Title ICMJE | A Dose Escalation, Randomized, Double-blind Withdrawal Study of the Efficacy, Dose-response, and Safety of Ramipril for the Treatment of Hypertension in Children and Adolescents | ||
| Brief Summary | Ramipril is an ACE inhibitor that has been marketed in the US for the treatment of hypertension since 1991. It has been shown to be effective in reducing both systolic and diastolic blood pressure in adults when used once daily. ACE inhibitors are frequently used to treat hypertension in children, however ramipril has not been extensively tested in children, and information regarding the efficacy and safety would therefore be of benefit to children. This study is designed to demonstrate the efficacy and safety of ramipril in the treatment of hypertension in children ages 6 through 16 years. | ||
| Detailed Description | In adults, common side effects include persistent dry mouth, dizziness, fatigue, and headache. Rare cases of angioedema have been reported. When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, ramipril should be discontinued as soon as possible. Ramipril is contraindicated in patients who are hypersensitive to the product or have a history of angioedema related to previous treatment with an ACE inhibitor. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment | ||
| Condition ICMJE | Hypertension | ||
| Intervention ICMJE | Drug: ramipril | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | 310 | ||
| Original Enrollment ICMJE | Same as current | ||
| Study Completion Date ICMJE | November 2004 | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 6 Years to 16 Years (Child) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00044265 | ||
| Other Study ID Numbers ICMJE | K726-01-4002 | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Pfizer | ||
| Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Pfizer | ||
| Verification Date | June 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||