Trial Outcomes & Findings for Effect of Valsartan Compared to Enalapril on Sitting Systolic Blood Pressure in Children With High Blood Pressure (NCT NCT00433836)

NCT ID: NCT00433836

Last Updated: 2011-05-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 300 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2011-05-19

Participant Flow

Participant milestones

Measure	Valsartan Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Overall Study STARTED	151	149
Overall Study COMPLETED	138	143
Overall Study NOT COMPLETED	13	6

Reasons for withdrawal

Measure	Valsartan Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Overall Study Adverse Event	7	0
Overall Study Lost to Follow-up	3	0
Overall Study Withdrawal by Subject	2	1
Overall Study Unsatisfactory therapeutic effect	1	1
Overall Study Protocol Violation	0	2
Overall Study Condition no longer requires study drug	0	1
Overall Study Abnormal laboratory values	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Valsartan n=151 Participants Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=149 Participants Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.	Total n=300 Participants Total of all reporting groups
Age Continuous	12.7 years STANDARD_DEVIATION 2.93 • n=5 Participants	13.0 years STANDARD_DEVIATION 2.94 • n=7 Participants	12.9 years STANDARD_DEVIATION 2.93 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	44 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	105 Participants n=7 Participants	191 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-treat. Only patients who had both baseline and endpoint values are included.

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

Outcome measures

Measure	Valsartan n=148 Participants Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=148 Participants Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP)	-15.4 mm Hg Standard Error 1.29	-14.1 mm Hg Standard Error 1.28

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Intent-to-treat. Only patients who had both baseline and endpoint values are included.

The change from baseline in mean sitting diastolic blood pressure (MSDBP) after 12 weeks of treatment as measured by office blood pressure.

Outcome measures

Measure	Valsartan n=148 Participants Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=148 Participants Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP)	-9.4 mm Hg Standard Error 0.94	-8.5 mm Hg Standard Error 0.95

SECONDARY outcome

Timeframe: at week 12

Population: Intent-to-treat. Only patients who had both baseline and endpoint values are included.

The percentage of children whose MSSBP decreased to <95th percentile for age, gender, and height on valsartan vs. enalapril monotherapy at week 12.

Outcome measures

Measure	Valsartan n=148 Participants Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=148 Participants Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Decrease in MSSBP to < 95th Percentile for Age, Gender and Height	66.9 Percentage of participants	70.3 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 8

Population: A subset of approximately 100 - 150 patients from selected centers was expected to undergo Ambulatory Blood Pressure Monitoring at baseline (Week 0) and at Week 8; however, only 56 patients chose to participate in this aspect of the study.

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.

Outcome measures

Measure	Valsartan n=26 Participants Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=30 Participants Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients ASBP	-9.8 mm Hg Standard Deviation 6.75	-6.8 mm Hg Standard Deviation 7.41
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (ASBP) and Mean Ambulatory Diastolic Blood Pressure (ADBP) Over 24 Hours in Subset of Patients ADBP	-9.3 mm Hg Standard Deviation 6.27	-5.5 mm Hg Standard Deviation 5.73

Adverse Events

Valsartan

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Enalapril

Serious events: 2 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Measure	Valsartan n=151 participants at risk Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=148 participants at risk Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Injury, poisoning and procedural complications Avulsion fracture	0.00% 0/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	0.68% 1/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Injury, poisoning and procedural complications Renal injury	0.00% 0/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	0.68% 1/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Dehydration	0.66% 1/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	0.00% 0/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	0.66% 1/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	0.00% 0/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Nervous system disorders Brain injury	0.66% 1/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	0.00% 0/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.

Other adverse events

Measure	Valsartan n=151 participants at risk Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.	Enalapril n=148 participants at risk Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
Infections and infestations Nasopharyngitis	6.6% 10/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	5.4% 8/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Infections and infestations Pharyngitis	4.0% 6/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	7.4% 11/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Infections and infestations Upper respiratory tract infection	6.6% 10/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	4.7% 7/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Nervous system disorders Headache	11.9% 18/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	18.9% 28/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	6.0% 9/151 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.	6.8% 10/148 Includes all patients who received at least one dose of post-randomization study drug; patients were analyzed according to the actual treatment received.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
• Publication restrictions are in place

Restriction type: OTHER