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

NCT00433836 | Completed Phase 3 Results

• 1 other identifier: CVAL489K2302
• Study Type: interventional
• Target: 300
• Locations: 11 countries
• Sites: 11

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).

Conditions

Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)

  Mean sitting systolic blood pressure (MSSBP) change after 12 weeks of treatment measured by office blood pressure measurement.

  Baseline and Week 12

Secondary Outcomes (3)

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)

  Baseline and Week 12

• Decrease in MSSBP to < 95th Percentile for Age, Gender and Height

  at week 12

• Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients

  Baseline and Week 8

Study Arms (6)

Valsartan 80 mg

EXPERIMENTAL

Drug: Valsartan

Valsartan 160 mg

EXPERIMENTAL

Drug: Valsartan

Valsartan 320 mg

EXPERIMENTAL

Drug: Valsartan

Enalapril 10 mg

ACTIVE COMPARATOR

Drug: Enalapril

Enalapril 20 mg

ACTIVE COMPARATOR

Drug: Enalapril

Enalapril 40 mg

ACTIVE COMPARATOR

Drug: Enalapril

Interventions

Valsartan DRUG

Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.

Valsartan 160 mg; Valsartan 320 mg; Valsartan 80 mg

Enalapril DRUG

Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.

Enalapril 10 mg; Enalapril 20 mg; Enalapril 40 mg

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Sites in USA

East Hanover, New Jersey, 07936, United States

Location

Sites in Belgium

Sites in Belgium, Belgium

Location

Sites in France

Sites in France, France

Location

Sites in Germany

Sites in Germany, Germany

Location

Sites in Hungary

Hungary, Hungary

Location

Sites in India

Sites in India, India

Location

Sites in Italy

Sites in Italy, Italy

Location

Sites in Poland

Poland, Poland

Location

Sites in Slovakia

Slovakia, Slovakia

Location

Sites in Sweden

Sites in Sweden, 00000, Sweden

Location

Sites in Turkey

Turkey, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Enalapril

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dipeptides; Oligopeptides; Peptides

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 12, 2007
• Study Start: January 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 19, 2011
• Results First Posted: May 19, 2011

Record last verified: 2011-04

Locations

IT (1); IN (1); FR (1); TU (1); HU (1); SL (1); SE (1); BE (1); PL (1); US (1); DE (1)