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: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Stage 1 Hypertension
Stage 2 Hypertension
Drug: Nebivolol and Valsartan 1
Drug: Nebivolol and Valsartan 2
Drug: Nebivolol and Valsartan 3
Drug: Nebivolol 1
Drug: Nebivolol 2
Drug: Valsartan 1
Drug: Valsartan 2
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change in Sitting Diastolic Blood Pressure (DBP) [ Time Frame: from basline to Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Sitting Systolic Blood Pressure (SBP) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]

Enrollment: 4161
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nebivolol and Valsartan Fixed Dose Combination 1
Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg
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
Experimental: Nebivolol and Valsartan Fixed Dose Combination 2
Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg
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
Experimental: Nebivolol and Valsartan Fixed Dose Combination 3
Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg
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
Experimental: Nebivolol Low Dose
Nebivolol Monotherapy 5 mg
Drug: Nebivolol 1
Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
Experimental: Nebivolol High Dose
Nebivolol Monotherapy 20 mg
Drug: Nebivolol 2
Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
Experimental: Valsartan Low Dose
Valsartan Monotherapy 80 mg
Drug: Valsartan 1
Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
Experimental: Valsartan High Dose
Valsartan Monotherapy 160 mg
Drug: Valsartan 2
Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
Placebo Comparator: Placebo
Dose Matched placebo
Drug: Placebo
Dose matched placebo, oral administration

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508026

  Show 413 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories
  More Information

No publications provided by Forest Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01508026     History of Changes
Other Study ID Numbers: NAC-MD-01
Study First Received: January 9, 2012
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
Stage 1
Stage 2
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Nebivolol
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on September 14, 2014