A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

A 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren 300 mg /Valsartan 320 mg in Patients With Essential Hypertension Followed by a 26 Week Open-label Extension to Assess the Long-term Safety and Tolerability of the Triple Combination of Aliskiren/Valsartan/Hydrochlorothiazide(HCTZ)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386607

Enrollment

601

Registered

2006-10-11

Start date

2006-10-31

Completion date

2008-07-31

Last updated

2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, aliskiren, valsartan, HCTZ, blood pressure

Brief summary

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).

Interventions

DRUGAliskiren

Aliskiren 300 mg

DRUGValsartan

Valsartan 320 mg

DRUGHydrochlorothiazide (HCTZ)

Hydrochlorothiazide (HCTZ) 12.5-25 mg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- * Male and female outpatients 18 years of age and older. * For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4 * For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4) * Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).

Exclusion criteria

* Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) * Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception. * History or evidence of a secondary form of hypertension. * History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Overall Percentage of Patients With Adverse Events	Month 12

Secondary

Measure	Time frame
Change From Baseline in Mean Sitting Systolic Blood Pressure.	Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg	.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Diastolic Blood Pressure.	Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Change From Baseline in Mean Sitting Systolic Blood Pressure	Baseline and Month 18
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment	Month 18
Change From Baseline in Mean Sitting Diastolic Blood Pressure	Baseline and Month 18

Countries

Canada, Germany, Netherlands, United States

Participant flow

Participants by arm

Arm	Count
Core Treatment Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.	601
Total	601

Withdrawals & dropouts

Period	Reason	FG000	FG001
Core	Abnormal laboratory value(s)	3	0
Core	Administrative problems	1	0
Core	Adverse Event	40	0
Core	Condition no longer requires study drug	4	0
Core	Lost to Follow-up	23	0
Core	Patient withdrew consent	15	0
Core	Protocol Deviation	6	0
Core	Unsatisfactory therapeutic effect	23	0
Extension	Abnormal laboratory value(s)	0	1
Extension	Administrative problems	0	1
Extension	Adverse Event	0	6
Extension	Lost to Follow-up	0	3
Extension	Patient withdrew consent	0	5
Extension	Unsatisfactory therapeutic effect	0	1

Baseline characteristics

Characteristic	Core Treatment
Age, Continuous	55.0 years STANDARD_DEVIATION 11.2
Sex: Female, Male Female	271 Participants
Sex: Female, Male Male	330 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	49 / 601	185 / 585	215 / 601	47 / 306	26 / 137	251 / 601
serious Total, serious adverse events	3 / 601	14 / 585	17 / 601	3 / 306	6 / 137	26 / 601

Outcome results

Primary

Overall Percentage of Patients With Adverse Events

adverse event data obtained from both the core study and the 6 month extension study.

Time frame: Month 18

Arm	Measure	Value (NUMBER)
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ	Overall Percentage of Patients With Adverse Events	61.6 percentage of patients

Primary

Overall Percentage of Patients With Adverse Events

Time frame: Month 12

Population: Treated population: All patients who received at least one dose of Aliskiren/Valsartan

Arm	Measure	Value (NUMBER)
Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ	Overall Percentage of Patients With Adverse Events	76.2 percentage of patients

Secondary