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CompletedNCT00386607Updated Feb 10, 2014Results posted

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 Phase 3 interventional study of Aliskiren and Valsartan in Hypertension, sponsored by Novartis. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-10.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
601
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension, aliskiren, valsartan, HCTZ, blood pressure
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 601 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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/exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
601 participants (actual)

Study arms

  • Experimental
    Core Treatment

    Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combination for 52-weeks, optional addition of Hydrochlorothiazide (HCTZ) 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (mean sitting Systolic Blood Pressure ≥ 140 and/or mean sitting Diastolic Blood Pressure ≥ 90 mmHg). The dose of Hydrochlorothiazide (HCTZ) 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.

    Drug: Aliskiren · Drug: Valsartan

  • Experimental
    Extension Treatment

    For patients entering into extension, those previously treated with Hydrochlorothiazide (HCTZ) 12.5 or 25 mg in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension. Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg. The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the mean sitting Systolic Blood Pressure (msSBP) was ≥140 mmHg and/or the mean sitting Diastolic Blood Pressure (msDBP) was ≥90 mmHg for 2 consecutive visits.

    Drug: Aliskiren · Drug: Valsartan · Drug: Hydrochlorothiazide (HCTZ)

Interventions

  • DrugAliskiren

    Aliskiren 300 mg

  • DrugValsartan

    Valsartan 320 mg

  • DrugHydrochlorothiazide (HCTZ)

    Hydrochlorothiazide (HCTZ) 12.5-25 mg

06

What researchers measure

Primary outcomes

  1. Overall Percentage of Patients With Adverse Events

    Time frame: Month 12

  2. 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

Secondary outcomes

  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure.

    Time frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54

  2. Change From Baseline in Mean Sitting Systolic Blood Pressure.

    Time frame: Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54

  3. Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg

    Time frame: .Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54

  4. Change From Baseline in Mean Sitting Diastolic Blood Pressure

    Time frame: Baseline and Month 18

  5. Change From Baseline in Mean Sitting Systolic Blood Pressure

    Time frame: Baseline and Month 18

  6. Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment

    Time frame: Month 18

07

Results

Posted May 10, 2011
Limitations and caveats
Open label study with no comparator treatment/arm.

Participant flow

Core
Participant flow — Core
MilestoneCore TreatmentExtension Treatment
Started6010
Completed4860
Not completed1150
Withdrew: Adverse event400
Withdrew: Abnormal laboratory value(s)30
Withdrew: Unsatisfactory therapeutic effect230
Withdrew: Condition no longer requires study drug40
Withdrew: Patient withdrew consent150
Withdrew: Lost to follow-up230
Withdrew: Administrative problems10
Withdrew: Protocol deviation60
Extension
Participant flow — Extension
MilestoneCore TreatmentExtension Treatment
Started0162
Completed0145
Not completed017
Withdrew: Adverse event06
Withdrew: Abnormal laboratory value(s)01
Withdrew: Administrative problems01
Withdrew: Lost to follow-up03
Withdrew: Patient withdrew consent05
Withdrew: Unsatisfactory therapeutic effect01

Outcome measures

PrimaryOverall Percentage of Patients With Adverse Events
Time frame:
Month 12
Reported as:
Number · percentage of patients
Overall Percentage of Patients With Adverse Events
percentage of patientsCore Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ
Overall Percentage of Patients With Adverse Events76.2
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure.
Time frame:
Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Reported as:
Mean · mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure.
mmHgCore Treatment
Week 2 (Visit 5)-7.9 ± 7.14
Week 4 (Visit 6)-10.8 ± 7.83
Week 6 (Visit 7)-11.8 ± 8.09
Week 10 (Visit 8)-12.5 ± 8.26
Week 14 (Visit 9)-13.7 ± 7.87
Week 18 (Visit 10)-15.0 ± 8.00
Week 28 (Visit 11)-15.2 ± 7.24
Week 41 (Visit 12)-15.2 ± 7.60
Week 54 (Visit 13)-14.2 ± 7.96
Endpoint (value at week 54 or LOCF)-13.4 ± 8.75
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure.
Time frame:
Baseline and Weeks 2, 4, 6, 10, 14, 18, 28, 41 and 54
Reported as:
Mean · mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure.
mmHgCore Treatment
Week 2 (Visit 5)-11.0 ± 12.42
Week 4 (Visit 6)-15.0 ± 14.03
Week 6 (Visit 7)-17.6 ± 14.10
Week 10 (Visit 8)-18.4 ± 14.37
Week 14 (Visit 9)-20.7 ± 13.42
Week 18 (Visit 10)-22.6 ± 14.01
Week 28 (Visit 11)-24.3 ± 13.70
Week 41 (Visit 12)-24.3 ± 13.27
Week 54 (Visit 13)-22.3 ± 14.51
Endpoint (value at week 54 or LOCF)-20.5 ± 16.40
SecondaryPercentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Time frame:
.Weeks 2, 4, 6, 10, 14, 18, 28, 41, and 54
Reported as:
Number · Percentage of patients
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg
Percentage of patientsCore Treatment
Week 2 (Visit 5)32.8
Week 4 (Visit 6)45.9
Week 6 (Visit 7)52.4
Week 10 (Visit 8)60.8
Week 14 (Visit 9)68.7
Week 18 (Visit 10)76.4
Week 28 (Visit 11)77.9
Week 41 (Visit 12)78.2
Week 54 (Visit 13)71.7
Endpoint (value at week 54 or LOCF)66.9
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure
Time frame:
Baseline and Month 18
Reported as:
Mean · mmHg
Change From Baseline in Mean Sitting Diastolic Blood Pressure
mmHgExtension Treatment
Change From Baseline in Mean Sitting Diastolic Blood Pressure-18.3 ± 8.52
PrimaryOverall 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
Reported as:
Number · percentage of patients
Overall Percentage of Patients With Adverse Events
percentage of patientsCore and Extension Treatment - Aliskiren/Valsartan/HCTZ
Overall Percentage of Patients With Adverse Events61.6
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure
Time frame:
Baseline and Month 18
Reported as:
Mean · mmHg
Change From Baseline in Mean Sitting Systolic Blood Pressure
mmHgExtension Treatment
Change From Baseline in Mean Sitting Systolic Blood Pressure-28.8 ± 14.80
SecondaryPercentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Time frame:
Month 18
Reported as:
Number · Percentage of patients
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment
Percentage of patientsExtension Treatment
Percentage of Patients Achieving Blood Pressure Control Target of < 140/90 mmHg in Extension Treatment86.6

Adverse events

Collected over 18 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone—3/601 (0.5%)49/601 (8.2%)
Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone—14/585 (2.4%)185/585 (31.6%)
Core Period: Aliskiren / Valsartan—17/601 (2.8%)215/601 (35.8%)
Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg—3/306 (1%)47/306 (15.4%)
Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg—6/137 (4.4%)26/137 (19%)
Core and Extension: Total—26/601 (4.3%)251/601 (41.8%)
Most frequent serious events
Showing 10 of 37
Most frequent serious events
EventCore Period: Aliskiren 150 mg / Valsartan 160 mg AloneCore Period: Aliskiren 300 mg / Valsartan 320 mg AloneCore Period: Aliskiren / ValsartanCore and Extension: Aliskiren / Valsartan / HCTZ 12.5 mgCore and Extension: Aliskiren / Valsartan / HCTZ 25 mgCore and Extension: Total
PainGeneral disorders0/6010/5850/6010/3061/1371/601
Clostridium difficile colitisInfections and infestations0/6010/5850/6010/3061/1371/601
Hepatitis BInfections and infestations0/6010/5850/6010/3061/1371/601
Peritoneal abscessInfections and infestations0/6010/5850/6010/3061/1371/601
Post-traumatic painInjury, poisoning and procedural complications0/6010/5850/6010/3061/1371/601
Thermal burnInjury, poisoning and procedural complications0/6010/5850/6010/3061/1371/601
HypoglycaemiaMetabolism and nutrition disorders0/6010/5850/6010/3061/1371/601
HypokalaemiaMetabolism and nutrition disorders0/6010/5850/6010/3061/1371/601
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders0/6010/5850/6010/3061/1371/601
OsteoarthritisMusculoskeletal and connective tissue disorders0/6011/5851/6010/3061/1372/601
Most frequent other events
Most frequent other events
EventCore Period: Aliskiren 150 mg / Valsartan 160 mg AloneCore Period: Aliskiren 300 mg / Valsartan 320 mg AloneCore Period: Aliskiren / ValsartanCore and Extension: Aliskiren / Valsartan / HCTZ 12.5 mgCore and Extension: Aliskiren / Valsartan / HCTZ 25 mgCore and Extension: Total
DizzinessNervous system disorders15/60139/58549/6016/3067/13761/601
NasopharyngitisInfections and infestations6/60139/58543/60110/3066/13754/601
HeadacheNervous system disorders16/60133/58545/6014/3062/13750/601
DiarrhoeaGastrointestinal disorders8/60127/58534/6019/3061/13742/601
Upper respiratory tract infectionInfections and infestations2/60125/58528/6019/3062/13738/601
BronchitisInfections and infestations3/60124/58527/6016/3063/13734/601
Back painMusculoskeletal and connective tissue disorders4/60119/58521/6015/3066/13732/601
CoughRespiratory, thoracic and mediastinal disorders1/60123/58524/6015/3065/13731/601

Baseline characteristics

Age, Continuous
Age, Continuous(years)Core Treatment
Mean55.0 ± 11.20
Sex: Female, Male
Sex: Female, Male(Participants)Core Treatment
Female271
Male330
08

Study locations

4 sites
  • Investigative Centers
    San Diego, California, United States
  • Investigative Centers
    Canada, Canada
  • Investigative Centers
    Germany, Germany
  • Investigative Centers
    Netherlands, Netherlands
09

References and documents

Publications

  • Chrysant SG, Murray AV, Hoppe UC, Dattani D, Patel S, Ritter S, Zhang J. Long-term safety and efficacy of aliskiren and valsartan combination with or without the addition of HCT in patients with hypertension. Curr Med Res Opin. 2010 Dec;26(12):2841-9. doi: 10.1185/03007995.2010.528282. Epub 2010 Nov 9. PubMed 21062137 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00386607
Lead sponsor
Novartis
First posted
Oct 11, 2006
Start date
Oct 2006
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
May 10, 2011
Last update
Feb 10, 2014

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

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