Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure

• ClinicalTrials.gov Identifier: NCT00433836
• Recruitment Status: Completed
• First Posted: February 12, 2007
• Results First Posted: May 19, 2011
• Last Update Posted: May 19, 2011
• Sponsor: Novartis Pharmaceuticals
• Information provided by: Novartis

Study Description

Brief Summary:

The purpose of this 12-week active controlled trial is to evaluate the safety and efficacy of valsartan 80/160/320 mg (weight stratified) compared with enalapril 10/20/40 mg (weight stratified) on sitting systolic blood pressure (SSBP) in 6 - 17 year old children with hypertension (SSBP ≥ 95th percentile for age gender and height).

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Valsartan; Drug: Enalapril	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Parallel-group, Evaluation of 12 Weeks of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children 6 to 17 Years of Age With Hypertension
• Study Start Date: January 2007
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Valsartan 80 mg	Drug: Valsartan; Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Experimental: Valsartan 160 mg	Drug: Valsartan; Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Experimental: Valsartan 320 mg	Drug: Valsartan; Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
Active Comparator: Enalapril 10 mg	Drug: Enalapril; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Active Comparator: Enalapril 20 mg	Drug: Enalapril; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Active Comparator: Enalapril 40 mg	Drug: Enalapril; Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) [ Time Frame: Baseline and Week 12 ]
   Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.

Secondary Outcome Measures :

1. Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) [ Time Frame: Baseline and Week 12 ]
   The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.
2. Decrease in MSSBP to < 95th Percentile for Age, Gender and Height [ Time Frame: at week 12 ]
   The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.
3. Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients [ Time Frame: Baseline and Week 8 ]
   The effect of valsartan and enalapril between baseline and visit 6 on 24-hour mean ambulatory systolic and diastolic blood pressure (ASBP, ADBP) in a subset of patients.

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or female, ages 6-17, with a documented history of hypertension
• Must be able to swallow a pill
• Must be ≥ 18 kg or ≤160 kg
• MSSBP (mean of 3 measurements) must be ≥ 95th percentile, for age, gender and height, at Visit 2 (randomization), by office blood pressure measurement
• Patients who are eligible and able to participate in the study and whose parent(s)/guardian(s) consent in writing (written informed consent) to their doing so after the purpose and nature of the investigation has been clearly explained to them. (An assent will be required for some patients depending upon their age and local requirements regarding assents)

Exclusion Criteria:

• Renal artery stenosis
• Current diagnosis of heart failure (NYHA Class II-IV).
• MSSBP ≥ 25% above the 95th percentile
• Second or third degree heart block without a pacemaker.
• Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
• Clinically significant valvular heart disease.
• Patient that demonstrates clinically significant ECG abnormalities other than those associated with left ventricular hypertrophy.
• Previous solid organ transplantation except renal, liver or heart transplantation. Renal, liver or heart transplant must have occurred at least 6 months prior to enrollment. Patient must be on stable doses of immunosuppressive therapy for 3 months and deemed clinically stable by the investigator.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

United States, New Jersey

Sites in USA

East Hanover, New Jersey, United States, 07936

Belgium

Sites in Belgium

Sites in Belgium, Belgium

France

Sites in France

Sites in France, France

Germany

Sites in Germany

Sites in Germany, Germany

Hungary

Sites in Hungary

Hungary, Hungary

India

Sites in India

Sites in India, India

Italy

Sites in Italy

Sites in Italy, Italy

Poland

Sites in Poland

Poland, Poland

Slovakia

Sites in Slovakia

Slovakia, Slovakia

Sweden

Sites in Sweden

Sites in Sweden, Sweden, 00000

Turkey

Sites in Turkey

Turkey, Turkey

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals; Novartis Pharmaceuticals

More Information

• Responsible Party: External Affairs, Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00433836
• Other Study ID Numbers: CVAL489K2302
• First Posted: February 12, 2007
• Results First Posted: May 19, 2011
• Last Update Posted: May 19, 2011
• Last Verified: April 2011

Keywords provided by Novartis:

Children; pediatrics; High Blood Pressure; Hypertension; Valsartan; enalapril

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Valsartan; Enalapril; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Angiotensin-Converting Enzyme Inhibitors; Protease Inhibitors; Enzyme Inhibitors