An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01281306
First received: January 20, 2011
Last updated: January 27, 2013
Last verified: January 2013

January 20, 2011
January 27, 2013
January 2011
December 2011   (final data collection date for primary outcome measure)
reduction in mean sitting systolic blood pressure (msSBP) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01281306 on ClinicalTrials.gov Archive Site
  • dose-response relationship in sitting diastolic blood pressure (msDBP) lowering of ascending doses of AHU377 in combination with valsartan 320 mg [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • changes in mean 24 hour ambulatory SBP (maSBP), mean 24 hour ambulatory DBP (maDBP), daytime and nighttime msSBP/maDBP of ascending doses of AHU377 in combination with valsartan 320mg as compared to valsartan 320mg monotherapy [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • office and ambulatory pulse pressure for all treatment groups [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • dose-response relationship in msSBP/msDBP and maSBP/maDBP lowering of ascending doses of AHU377 in combination with valsartan 320mg by sub-group analysis of age (< 65 and ≥ 65) [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events, serious adverse events, and notable laboratory abnormalities [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An 8-week Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg in Patients With Mild-to-moderate Systolic Hypertension
A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group Study to Evaluate the Dose Response of AHU377 in Combination With Valsartan 320 mg After 8 Week Treatment in Patients With Mild-to-moderate Systolic Hypertension

The purpose of the study is to evaluate dose response of blood pressure lowering for 4 doses of AHU377, given once daily (50 mg, 100 mg, 200 mg and 400 mg) in combination with a fixed dose of valsartan (320 mg).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Systolic Hypertension
  • Drug: LCZ696
    LCZ696 400 mg, LCZ696 200 mg
  • Drug: AHU377
    AHU377 100 mg, AHU377 50 mg
  • Drug: Valsartan
    Valsartan 320 mg, Valsartan 160 mg
  • Drug: placebo
  • Experimental: LCZ696 400 mg
    patients will start with 200mg LCZ696 qd for one week, thereafter they will be up-titrated to 400 mg LCZ696 given once daily for the remaining 7 weeks
    Intervention: Drug: LCZ696
  • Experimental: AHU377 400 mg + valsartan 320 mg
    patients will start with AHU377 100mg + valsartan 160 mg for one week, they will be up-titrated to AHU377 200 mg + valsartan 320 mg for one week and thereafter they will be up-titrated to AHU377 400 mg +valsartan 320 mg for the remaining 6 weeks
    Interventions:
    • Drug: AHU377
    • Drug: Valsartan
  • Experimental: AHU377 200 mg + valsartan 320 mg
    patients will start with AHU377 100 mg + valsartan 160 mg for one week, thereafter they will be up-titrated to AHU377 200 mg + valsartan 320 mg for the remaining 7 weeks
    Interventions:
    • Drug: AHU377
    • Drug: Valsartan
  • Experimental: AHU377 100 mg + valsartan 320 mg
    patient will start with AHU377 50 mg + valsartan 160 mg for one week, thereafter they will be up-titrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks
    Interventions:
    • Drug: AHU377
    • Drug: Valsartan
  • Experimental: AHU377 50 mg + valsartan 320 mg
    patients will start with AHU377 50 mg + valsartan 160 mg for one week, thereafter they will be up-titrated to AHU377 50 mg + valsartan 320 mg for the remaining 7 weeks
    Interventions:
    • Drug: AHU377
    • Drug: Valsartan
  • Experimental: valsartan 320 mg
    patients will start with valsartan 160 mg for one week, thereafter they will be up-titrated to valsartan 320 mg for the remaining 7 weeks
    Intervention: Drug: Valsartan
  • Experimental: placebo
    patients will receive matching placebo for 8 weeks
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1301
December 2011
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed. Patients with mild-to-moderate systolic hypertension, untreated or currently taking antihypertensive therapy.
  • Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the run-in period.

Exclusion Criteria:

  • Severe hypertension
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • Pregnant or nursing (lactating) women.
  • Women of child-bearing potential (WOCBP), UNLESS they are using adequate birth control methods.
  • History or evidence of a secondary form of hypertension.
  • Other protocol-defined inclusion/exclusion criteria may apply
Both
18 Years to 76 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Hungary,   India,   Korea, Republic of,   Romania,   Slovakia,   Spain
 
NCT01281306
CLCZ696A2223, 2010-022326-32
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP