Combination of Nebivolol and Valsartan Given as Free Tablets for Stage 1 or Stage 2 Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01415505
First received: August 10, 2011
Last updated: May 31, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the safety and tolerability of nebivolol and valsartan given as a free tablet combination in patient with stage 1 or stage 2 essential hypertension.


Condition Intervention Phase
Hypertension
Drug: Nebivolol, Valsartan and Hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Single-Arm, Free Tablet Combination, Long-Term Study to Evaluate the Safety of Nebivolol in Combination With Valsartan in Patients With Stage 1 or Stage 2 Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Adverse Event Recording [ Time Frame: From Baseline to Week 53 (Visit 16) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Diastolic Blood Pressure (DBP). [ Time Frame: From Baseline to Week 52 (Visit 15) ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure (SBP) [ Time Frame: From Baseline to Week 52 (Visit 15) ] [ Designated as safety issue: No ]

Enrollment: 812
Study Start Date: August 2011
Study Completion Date: April 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Nebivolol and Valsartan free tablet combination
Drug: Nebivolol, Valsartan and Hydrochlorothiazide
Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), 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
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • History of Type 1 diabetes mellitus
  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: NCT01415505

  Show 135 Study Locations
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: David B Bharucha, MD, PhD, FACC Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01415505     History of Changes
Other Study ID Numbers: NAC-MD-02
Study First Received: August 10, 2011
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Forest Laboratories:
Stage 1
Stage 2
Hypertension
1 year open label safety study

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Nebivolol
Hydrochlorothiazide
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Vasodilator Agents
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 29, 2014