NCT02336607

Brief Summary

The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
529

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Dec 2005

Shorter than P25 for not_applicable hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 23, 2015

Completed
Last Updated

March 23, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

November 25, 2014

Results QC Date

January 12, 2015

Last Update Submit

March 13, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 14 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.

    14 weeks

Secondary Outcomes (11)

  • The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.

    4 weeks

  • The Percentage of Subjects Reaching Blood Pressure Target (Defined as < 140 / 90 mmHg) After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.

    8 weeks

  • The Magnitude of Systolic and Diastolic Blood Pressure Change From Baseline Among All Randomized Subjects After 4 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.

    4 weeks

  • The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 8 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.

    8 weeks

  • The Magnitude of Systolic and Diastolic Blood Pressure Changes From Baseline Among All Randomized Subjects After 12 Weeks of Felodipine Sustained Release in Combination With Metoprolol, Lisinopril or Hydrochlorothiazide.

    12 weeks

  • +6 more secondary outcomes

Study Arms (4)

Felodipine tablet (Plendil)

EXPERIMENTAL
Drug: Felodipine tablet (Plendil) alone

Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)

ACTIVE COMPARATOR
Drug: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)

Felodipine tablets (Plendil)+Lisinopril (Zestril)

ACTIVE COMPARATOR
Drug: Felodipine tablets (Plendil)+Lisinopril (Zestril)

Felodipine tablet (Plendil)+Hydrochlorothiazide

ACTIVE COMPARATOR
Drug: Felodipine tablet (Plendil)+Hydrochlorothiazide

Interventions

Felodipine tablet (Plendil) aloneDRUG

Felodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th week).

Felodipine tablet (Plendil)
Felodipine tablet (Plendil)+HydrochlorothiazideDRUG

Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with hydrochlorothiazide 12.5mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.

Felodipine tablet (Plendil)+Hydrochlorothiazide
Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)DRUG

Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with metoprolol succinate prolonged-release tablet (Betaloc ZOK) 47.5mg , once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.

Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)
Felodipine tablets (Plendil)+Lisinopril (Zestril)DRUG

Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with Lisinopril (Zestril) 10mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled.

Felodipine tablets (Plendil)+Lisinopril (Zestril)

Eligibility Criteria

Age35 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of written informed consent
  • Female or male aged between 35-79 years old
  • Mild to moderate essential hypertension patients who meet any of the following criterias:
  • Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, moderate essential hypertension patients. (160mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg)
  • Newly diagnosed, drug-naive, or without any antihypertension treatment for at least 3 months, mild essential hypertension patients (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk (a)(having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).
  • (a) according to Chinese guideline for prevention and treatment of patients with hypertension 2004.
  • The patients have already received starting dosage of single anti-hypertension drug therapy (exclude the drugs containing felodipine component ), however the blood pressure is not well controlled (140mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg). After stopping the drug for 5 eliminating half life time, the patients meet any one of the following two:
  • mmHg mean SiSBP 180mmHg or 100mmHg mean SiDBP 110mmHg.
  • mmHg mean SiSBP 160mmHg or 90mmHg mean SiDBP 100mmHg) with high or extreme high cardiovascular risk\* (having 3 or more than 3 risk factors and/or target organ lesion and/or diabetes mellitus).
  • Sitting blood pressure is taken after subjects take a seat to rest for 5 minutes before the next medication.

You may not qualify if:

  • Known or suspected secondary hypertension
  • Resting heart rate is \< 55bpm.
  • Sick sinus syndrome
  • Atrioventricular block of first degree (with P-R\>0.24seconds), or second or third degree
  • Other clinical significant arrhythmia
  • Unstable and/or decompensated congestive heart failure
  • Angina, acute myocardial infarction, percutaneous coronary intervention (PCI), or cardiac surgery
  • Asthma or moderate to severe chronic obstructive pulmonary disease
  • Type 1 diabetes mellitus
  • Gout history
  • Fasting serum glucose of greater than 200 mg/dl (11.1 mmol/L) or type 2 diabetes mellitus needs insulin therapy
  • ALT\>3ULN
  • Cr\>1.5mg/dl
  • Pregnancy or lactation.
  • Alcohol or drug abuse
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hypertension

Interventions

FelodipineSingle PersonLisinopril

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic FactorsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
BP of Astrazeneca
Organization
Astrazeneca
aztrial_results_posting@astrazeneca.com
+86 21 60302288

Study Officials

  • Ningling Sun, PhD, MD

    Beijing University People's Hospital, Department of Cardiology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2014

First Posted

January 13, 2015

Study Start

December 1, 2005

Primary Completion

June 1, 2006

Study Completion

August 1, 2006

Last Updated

March 23, 2015

Results First Posted

March 23, 2015

Record last verified: 2015-03