Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01508026
First received: January 9, 2012
Last updated: May 31, 2013
Last verified: May 2013

January 9, 2012
May 31, 2013
January 2012
March 2013   (final data collection date for primary outcome measure)
Change in Sitting Diastolic Blood Pressure (DBP) [ Time Frame: from basline to Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01508026 on ClinicalTrials.gov Archive Site
Change in Sitting Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of the Efficacy and Safety of the Combination of Two FDA Approved Oral Medications, Nebivolol and Valsartan for Treatment of Stage 1 or 2 Hypertension
A Multicenter, Randomized, Double-blind, Placebo-Controlled, 8-Week Study to Evaluate the Safety and Efficacy of Nebivolol and Valsartan Given as a Fixed Dose Combination in Patients With Stage 1 or 2 Essential Hypertension

To evaluate the efficacy and safety of fixed-dose combination of nebivolol and valsartan compared to monotherapy and placebo in patients with stage 1 and stage 2 hypertension.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Stage 1 Hypertension
  • Stage 2 Hypertension
  • Drug: Nebivolol and Valsartan 1
    Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
  • Drug: Nebivolol and Valsartan 2
    Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
  • Drug: Nebivolol and Valsartan 3
    Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
  • Drug: Nebivolol 1
    Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
  • Drug: Nebivolol 2
    Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
  • Drug: Valsartan 1
    Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
  • Drug: Valsartan 2
    Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
  • Drug: Placebo
    Dose matched placebo, oral administration
  • Experimental: Nebivolol and Valsartan Fixed Dose Combination 1
    Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
    Intervention: Drug: Nebivolol and Valsartan 1
  • Experimental: Nebivolol and Valsartan Fixed Dose Combination 2
    Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg
    Intervention: Drug: Nebivolol and Valsartan 2
  • Experimental: Nebivolol and Valsartan Fixed Dose Combination 3
    Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
    Intervention: Drug: Nebivolol and Valsartan 3
  • Experimental: Nebivolol Low Dose
    Nebivolol Monotherapy 5 mg
    Intervention: Drug: Nebivolol 1
  • Experimental: Nebivolol High Dose
    Nebivolol Monotherapy 20 mg
    Intervention: Drug: Nebivolol 2
  • Experimental: Valsartan Low Dose
    Valsartan Monotherapy 80 mg
    Intervention: Drug: Valsartan 1
  • Experimental: Valsartan High Dose
    Valsartan Monotherapy 160 mg
    Intervention: Drug: Valsartan 2
  • Placebo Comparator: Placebo
    Dose Matched placebo
    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
4161
May 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients of age 18 years or above
  • Patients diagnosed with stage 1 or stage 2 essential hypertension
  • Normal physical examination findings, electrocardiogram (ECG) results and chest x-ray; or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

  • Secondary hypertension or severe hypertension
  • Clinically significant cardiovascular disease or heart failure
  • Clinical significant respiratory disease that would prohibit the use of a beta blocker
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • History of Type 1 diabetes mellitus
  • History of Severe Mental Illness except mild depression
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01508026
NAC-MD-01
No
Forest Laboratories
Forest Laboratories
Not Provided
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories
Forest Laboratories
May 2013

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